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The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00700817
Collaborator
(none)
665
Enrollment
166
Locations
5
Arms
24
Duration (Months)
4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:
  1. Week 27-52 after randomisation
  • All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
  1. Week 53-78 after randomisation

  • Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.

  • Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
665 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg

Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

Drug: liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection

Drug: metformin
Tablets, minimum 1500 mg daily
Experimental: Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg

Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

Drug: metformin
Tablets, minimum 1500 mg daily

Drug: liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection
Active Comparator: Sita -> Sita

Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).

Drug: sitagliptin
Tablets, 100 mg daily

Drug: metformin
Tablets, minimum 1500 mg daily
Experimental: Sita -> Sita -> Lira 1.2 mg

Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.

Drug: liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection

Drug: sitagliptin
Tablets, 100 mg daily

Drug: metformin
Tablets, minimum 1500 mg daily
Experimental: Sita -> Sita -> Lira 1.8 mg

Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.

Drug: sitagliptin
Tablets, 100 mg daily

Drug: metformin
Tablets, minimum 1500 mg daily

Drug: liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection

Outcome Measures

Primary Outcome Measures

  1. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

  2. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

  3. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 [Week 0, Week 78]

    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

  4. Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 [Week 52, Week 78]

    Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78

Secondary Outcome Measures

  1. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 [Week 0, Week 26]

    Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26

  2. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52

  3. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 [Week 0, Week 78]

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.

  4. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 [Week 0, Week 78]

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.

  5. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 [Week 0, Week 26]

    Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26

  6. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52

  7. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 [Week 0, Week 78]

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.

  8. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 [Week 0, Week 78]

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.

  9. Mean Change From Baseline in Body Weight at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in body weight at Week 26.

  10. Mean Change From Baseline in Body Weight at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in body weight at Week 52.

  11. Mean Change in Body Weight From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in body weight from Week 52 to Week 78.

  12. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

  13. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

  14. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 [Week 0, Week 78]

    Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

  15. Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

  16. Mean Change From Baseline in Beta-cell Function at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

  17. Mean Change From Baseline in Beta-cell Function at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

  18. Mean Change in Beta-cell Function From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

  19. Mean Change From Baseline in Total Cholesterol at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

  20. Mean Change From Baseline in Total Cholesterol at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

  21. Mean Change in Total Cholesterol From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in total cholesterol from Week 52 to Week 78

  22. Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

  23. Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

  24. Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

  25. Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

  26. Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

  27. Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

  28. Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

  29. Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

  30. Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 [Week 52, Week 78]

    Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

  31. Mean Change From Baseline in Triglycerides (TG) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

  32. Mean Change From Baseline in Triglycerides (TG) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

  33. Mean Change in Triglycerides (TG) From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in triglycerides (TG) from Week 52 to Week 78.

  34. Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

  35. Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

  36. Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in free fatty acids (FFA) from Week 52 to Week 78.

  37. Mean Change From Baseline in Apolipoprotein B at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

  38. Mean Change From Baseline in Apolipoprotein B at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

  39. Mean Change in Apolipoprotein B From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

  40. Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

  41. Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

  42. Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

  43. Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

  44. Mean Change From Baseline in Adiponectin at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

  45. Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

  46. Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.

  47. Mean Change From Baseline in Waist to Hip Ratio at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

  48. Mean Change From Baseline in Waist to Hip Ratio at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

  49. Mean Change in Waist to Hip Ratio From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

  50. Mean Change From Baseline in Waist Circumference at Week 26. [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

  51. Mean Change From Baseline in Waist Circumference at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

  52. Mean Change in Waist Circumference From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in Waist Circumference from Week 52 to Week 78.

  53. Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

  54. Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

  55. Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

  56. Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

  57. Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

  58. Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

  59. Mean Change From Baseline in Pulse at Week 26 [Week 0, Week 26]

    Calculated as an estimate of the mean change from baseline in pulse at Week 26.

  60. Mean Change From Baseline in Pulse at Week 52 [Week 0, Week 52]

    Calculated as an estimate of the mean change from baseline in pulse at Week 52.

  61. Mean Change in Pulse From Week 52 to Week 78 [Week 52, Week 78]

    Mean change in pulse from Week 52 to Week 78.

  62. Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 [Week 0, Week 26]

    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

  63. Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 [Week 0, Week 52]

    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

  64. Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 [Week 52, Week 78]

    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

  65. Hypoglyceamic Episodes, Weeks 0-26 [Weeks 0-26]

    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  66. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 [Weeks 0-26]

    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  67. Hypoglyceamic Episodes, Weeks 0-52 [Weeks 0-52]

    Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  68. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 [Weeks 0-52]

    Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  69. Hypoglyceamic Episodes, Weeks 0-78 [Weeks 0-78]

    Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  70. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 [Weeks 0-78]

    Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  71. Hypoglycaamic Episodes, Weeks 52-78 [Week 52-78]

    Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Type 2 diabetes

  • Treatment with metformin alone for at least three months

  • HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)

  • Body Mass Index (BMI) less than or equal to 45.0

Exclusion Criteria:

  • Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors

  • Treatment with anti-diabetic drugs other than metformin within the last three months

  • Any serious medical condition

  • Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Birmingham Alabama United States 35242
2 Novo Nordisk Investigational Site Escondido California United States 92025
3 Novo Nordisk Investigational Site Fresno California United States 93720
4 Novo Nordisk Investigational Site Huntington Beach California United States 92646
5 Novo Nordisk Investigational Site Long Beach California United States 90822
6 Novo Nordisk Investigational Site Northridge California United States 91325
7 Novo Nordisk Investigational Site Orange California United States 92869
8 Novo Nordisk Investigational Site Poway California United States 92064
9 Novo Nordisk Investigational Site Walnut Creek California United States 94598
10 Novo Nordisk Investigational Site Denver Colorado United States 80209
11 Novo Nordisk Investigational Site Crystal River Florida United States 34429
12 Novo Nordisk Investigational Site Jacksonville Florida United States 32205
13 Novo Nordisk Investigational Site Jacksonville Florida United States 32216
14 Novo Nordisk Investigational Site Miami Florida United States 33169
15 Novo Nordisk Investigational Site Ocala Florida United States 34471
16 Novo Nordisk Investigational Site Panama City Florida United States 32401
17 Novo Nordisk Investigational Site St. Cloud Florida United States 34769
18 Novo Nordisk Investigational Site Athens Georgia United States 30606
19 Novo Nordisk Investigational Site Atlanta Georgia United States 30342
20 Novo Nordisk Investigational Site Dunwoody Georgia United States 30338
21 Novo Nordisk Investigational Site Lithia Springs Georgia United States 30122
22 Novo Nordisk Investigational Site Honolulu Hawaii United States 96814
23 Novo Nordisk Investigational Site Boise Idaho United States 83702
24 Novo Nordisk Investigational Site Chicago Illinois United States 60616
25 Novo Nordisk Investigational Site Shawnee Mission Kansas United States 66204
26 Novo Nordisk Investigational Site Metairie Louisiana United States 70002
27 Novo Nordisk Investigational Site Hyattsville Maryland United States 20782
28 Novo Nordisk Investigational Site Minneapolis Minnesota United States 55416
29 Novo Nordisk Investigational Site Cleveland Mississippi United States 38732
30 Novo Nordisk Investigational Site St. Peters Missouri United States 63376
31 Novo Nordisk Investigational Site Las Vegas Nevada United States 89109
32 Novo Nordisk Investigational Site Berlin New Jersey United States 08009
33 Novo Nordisk Investigational Site Northport New York United States 11768
34 Novo Nordisk Investigational Site Rosedale New York United States 11422
35 Novo Nordisk Investigational Site Pinehurst North Carolina United States 28374
36 Novo Nordisk Investigational Site Tabor City North Carolina United States 28463
37 Novo Nordisk Investigational Site Cincinnati Ohio United States 45245
38 Novo Nordisk Investigational Site Columbus Ohio United States 43201
39 Novo Nordisk Investigational Site Cuyahoga Falls Ohio United States 44223
40 Novo Nordisk Investigational Site Dayton Ohio United States 45406
41 Novo Nordisk Investigational Site Dayton Ohio United States 45439
42 Novo Nordisk Investigational Site Mentor Ohio United States 44060
43 Novo Nordisk Investigational Site Eugene Oregon United States 97404
44 Novo Nordisk Investigational Site Altoona Pennsylvania United States 16602
45 Novo Nordisk Investigational Site Norristown Pennsylvania United States 19401
46 Novo Nordisk Investigational Site Kingsport Tennessee United States 37660
47 Novo Nordisk Investigational Site Arlington Texas United States 76014
48 Novo Nordisk Investigational Site Dallas Texas United States 75230
49 Novo Nordisk Investigational Site Houston Texas United States 77024
50 Novo Nordisk Investigational Site Houston Texas United States 77030
51 Novo Nordisk Investigational Site Hurst Texas United States 76054
52 Novo Nordisk Investigational Site New Braunfels Texas United States 78130
53 Novo Nordisk Investigational Site San Antonio Texas United States 78229
54 Novo Nordisk Investigational Site Sugar Land Texas United States 77479
55 Novo Nordisk Investigational Site Ogden Utah United States 84403
56 Novo Nordisk Investigational Site St. George Utah United States 84790
57 Novo Nordisk Investigational Site South Burlington Vermont United States 05403
58 Novo Nordisk Investigational Site Newport News Virginia United States 23606
59 Novo Nordisk Investigational Site Richmond Virginia United States 23294
60 Novo Nordisk Investigational Site Milwaukee Wisconsin United States 53209
61 Novo Nordisk Investigational Site Edmonton Alberta Canada T5A 4L8
62 Novo Nordisk Investigational Site Vancouver British Columbia Canada V5Z 1M9
63 Novo Nordisk Investigational Site London Ontario Canada N6G 2M1
64 Novo Nordisk Investigational Site Newmarket Ontario Canada L4Y 8E3
65 Novo Nordisk Investigational Site Ottawa Ontario Canada K1N 6N5
66 Novo Nordisk Investigational Site Toronto Ontario Canada M3J 1N2
67 Novo Nordisk Investigational Site Toronto Ontario Canada M5C 2T2
68 Novo Nordisk Investigational Site Toronto Ontario Canada M5T 3L9
69 Novo Nordisk Investigational Site Montreal Quebec Canada H2W 1T8
70 Novo Nordisk Investigational Site Montreal Quebec Canada H3J 2V5
71 Novo Nordisk Investigational Site Hamilton Canada L8M 1K7
72 Novo Nordisk Investigational Site Karlovac Croatia 47000
73 Novo Nordisk Investigational Site Sisak Croatia 44000
74 Novo Nordisk Investigational Site Slavonski Brod Croatia 35 000
75 Novo Nordisk Investigational Site Belgrade Former Serbia and Montenegro 11000
76 Novo Nordisk Investigational Site Nis Former Serbia and Montenegro 18000
77 Novo Nordisk Investigational Site LA ROCHE-sur-YON cedex 9 France 85295
78 Novo Nordisk Investigational Site LA ROCHELLE cedex France 17019
79 Novo Nordisk Investigational Site Limoges France 87042
80 Novo Nordisk Investigational Site Narbonne France 11108
81 Novo Nordisk Investigational Site Rennes France 35056
82 Novo Nordisk Investigational Site Saint Mandé France 94160
83 Novo Nordisk Investigational Site Strasbourg France 67000
84 Novo Nordisk Investigational Site Venissieux France 69200
85 Novo Nordisk Investigational Site Bad Lauterberg Germany 37431
86 Novo Nordisk Investigational Site Bochum Germany 44791
87 Novo Nordisk Investigational Site Dormagen Germany 41539
88 Novo Nordisk Investigational Site Frankfurt Germany 60388
89 Novo Nordisk Investigational Site Herrenberg Germany 71083
90 Novo Nordisk Investigational Site Kassel Germany 34117
91 Novo Nordisk Investigational Site Marburg Germany 35039
92 Novo Nordisk Investigational Site Riesa Germany 01587
93 Novo Nordisk Investigational Site Schönebeck Germany 39218
94 Novo Nordisk Investigational Site Ulm Germany 89073
95 Novo Nordisk Investigational Site Völklingen Germany 66333
96 Novo Nordisk Investigational Site Wangen Germany 88239
97 Novo Nordisk Investigational Site Dublin 9 Ireland
98 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 15
99 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 4
100 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 7
101 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 8
102 Novo Nordisk Investigational Site Catania Italy 95124
103 Novo Nordisk Investigational Site Lucca Italy 55100
104 Novo Nordisk Investigational Site Messina Italy 98123
105 Novo Nordisk Investigational Site Olbia Italy 07026
106 Novo Nordisk Investigational Site Palermo Italy 90123
107 Novo Nordisk Investigational Site Pavia Italy 27100
108 Novo Nordisk Investigational Site Roma Italy 00161
109 Novo Nordisk Investigational Site Siena Italy 53100
110 Novo Nordisk Investigational Site Trieste Italy 34148
111 Novo Nordisk Investigational Site Almere Netherlands 1311RL
112 Novo Nordisk Investigational Site Apeldoorn Netherlands 7334 DZ
113 Novo Nordisk Investigational Site Beek Netherlands 6191JW
114 Novo Nordisk Investigational Site Groningen Netherlands 9728 NT
115 Novo Nordisk Investigational Site Hengelo Netherlands 7555 DL
116 Novo Nordisk Investigational Site Leiden Netherlands 2333 ZA
117 Novo Nordisk Investigational Site Roelofarendsveen Netherlands 2371 RB
118 Novo Nordisk Investigational Site Stadskanaal Netherlands 9501 EH
119 Novo Nordisk Investigational Site Zevenaar Netherlands 6903 ZN
120 Novo Nordisk Investigational Site Zoetermeer Netherlands 2725 NA
121 Novo Nordisk Investigational Site Caquas Puerto Rico 00725
122 Novo Nordisk Investigational Site Guaynabo Puerto Rico 00968
123 Novo Nordisk Investigational Site Manati Puerto Rico 00674
124 Novo Nordisk Investigational Site Rio Piedras Puerto Rico 00921
125 Novo Nordisk Investigational Site Trujillo Alto Puerto Rico 00976
126 Novo Nordisk Investigational Site Oradea Bihor Romania 410469
127 Novo Nordisk Investigational Site Craiova Dolj Romania 200642
128 Novo Nordisk Investigational Site Bucharest Romania 020614
129 Novo Nordisk Investigational Site Timisoara Romania 300736
130 Novo Nordisk Investigational Site Bratislava Slovakia 811 08
131 Novo Nordisk Investigational Site Bratislava Slovakia 82102
132 Novo Nordisk Investigational Site Bratislava Slovakia 851 05
133 Novo Nordisk Investigational Site Nitra Slovakia 94 911
134 Novo Nordisk Investigational Site Nove Zamky Slovakia 940 59
135 Novo Nordisk Investigational Site Ljubljana Slovenia 1525
136 Novo Nordisk Investigational Site Novo mesto Slovenia 8000
137 Novo Nordisk Investigational Site Trbovlje Slovenia 1420
138 Novo Nordisk Investigational Site Alzira Spain 46600
139 Novo Nordisk Investigational Site Barcelona Spain 08036
140 Novo Nordisk Investigational Site Getafe Spain 28905
141 Novo Nordisk Investigational Site Hospitalet de Llobregat Spain 08907
142 Novo Nordisk Investigational Site Málaga Spain 29010
143 Novo Nordisk Investigational Site Oviedo Spain 33006
144 Novo Nordisk Investigational Site Palma de Mallorca Spain 07010
145 Novo Nordisk Investigational Site Palma de Mallorca Spain 07014
146 Novo Nordisk Investigational Site Puerto del Rosario Spain 35600
147 Novo Nordisk Investigational Site Aberdeen United Kingdom AB25 1LD
148 Novo Nordisk Investigational Site Abergavenny United Kingdom NP7 7EG
149 Novo Nordisk Investigational Site Aldershot United Kingdom GU12 5BA
150 Novo Nordisk Investigational Site Ayr United Kingdom KA6 6DX
151 Novo Nordisk Investigational Site Birmingham United Kingdom B9 5SS
152 Novo Nordisk Investigational Site Chippenham United Kingdom SN15 2SB
153 Novo Nordisk Investigational Site Coventry United Kingdom CV6 2FL
154 Novo Nordisk Investigational Site Edgbaston, Birmingham United Kingdom B15 2TH
155 Novo Nordisk Investigational Site Edinburgh United Kingdom EH16 4SA
156 Novo Nordisk Investigational Site Edinburgh United Kingdom EH4 2XU
157 Novo Nordisk Investigational Site Glasgow United Kingdom G45 9AW
158 Novo Nordisk Investigational Site Leicester United Kingdom LE1 5WW
159 Novo Nordisk Investigational Site Letchworth United Kingdom SG6 4UB
160 Novo Nordisk Investigational Site Liverpool United Kingdom L9 7AL
161 Novo Nordisk Investigational Site Maidstone United Kingdom ME16 9QQ
162 Novo Nordisk Investigational Site Nottingham United Kingdom NG7 2UH
163 Novo Nordisk Investigational Site Oxford United Kingdom OX3 7LE
164 Novo Nordisk Investigational Site Salford United Kingdom M6 8HD
165 Novo Nordisk Investigational Site Sheffield United Kingdom S5 7AU
166 Novo Nordisk Investigational Site Swansea United Kingdom SA6 6NL

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00700817
Other Study ID Numbers:
  • NN2211-1860
  • 2007-003937-17
First Posted:
Jun 19, 2008
Last Update Posted:
Mar 8, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metformin
Sitagliptin Phosphate
Liraglutide

Study Results

Participant Flow

Recruitment Details A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.
Pre-assignment Detail Between screening and randomisation, eligible subjects were to continue their usual pre-study metformin dose and dosing frequency.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Period Title: Week 0-26 (Main Period)
STARTED 225 221 219 0 0
Exposed 221 218 219 0 0
COMPLETED 169 191 194 0 0
NOT COMPLETED 56 30 25 0 0
Period Title: Week 0-26 (Main Period)
STARTED 155 176 166 0 0
COMPLETED 135 150 151 0 0
NOT COMPLETED 20 26 15 0 0
Period Title: Week 0-26 (Main Period)
STARTED 134 150 0 67 68
COMPLETED 124 135 0 59 63
NOT COMPLETED 10 15 0 8 5

Baseline Characteristics

Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg Total
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin. Total of all reporting groups
Overall Participants 225 221 219 0 0 665
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
55.9
(9.6)
55.0
(9.1)
55.0
(9.0)
55.3
(9.2)
Sex: Female, Male (Count of Participants)
Female
109
48.4%
105
47.5%
99
45.2%
313
Infinity
Male
116
51.6%
116
52.5%
120
54.8%
352
Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
39
17.3%
34
15.4%
35
16%
108
Infinity
Not Hispanic or Latino
186
82.7%
187
84.6%
184
84%
557
Infinity
Unknown or Not Reported
0
0%
0
0%
0
0%
0
NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
3
1.3%
0
0%
0
0%
3
Infinity
Asian
6
2.7%
4
1.8%
1
0.5%
11
Infinity
Native Hawaiian or Other Pacific Islander
1
0.4%
0
0%
1
0.5%
2
Infinity
Black or African American
22
9.8%
16
7.2%
10
4.6%
48
Infinity
White
184
81.8%
193
87.3%
199
90.9%
576
Infinity
More than one race
0
0%
0
0%
0
0%
0
NaN
Unknown or Not Reported
9
4%
8
3.6%
8
3.7%
25
Infinity
Body Mass Index (BMI) at Screening (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
32.6
(5.2)
33.1
(5.1)
32.6
(5.4)
32.8
(5.2)
Duration of Diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
6.0
(4.5)
6.4
(5.4)
6.3
(5.4)
6.2
(5.1)
Fasting Plasma Glucose (FPG) at Randomisation (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]
10.1
(2.4)
9.9
(2.4)
10.0
(2.0)
10.0
(2.3)
Glycosylated Haemoglobin A1c (HbA1c) at Randomisation (Percentage point of total HbA1c) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage point of total HbA1c]
8.4
(0.8)
8.4
(0.7)
8.5
(0.7)
8.4
(0.8)

Outcome Measures

1. Primary Outcome
Title Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Description Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 211 214 210 0 0
Least Squares Mean (Standard Error) [Percentage point of total HbA1c]
-1.24
(0.07)
-1.5
(0.06)
-0.9
(0.07)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis p-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.6
Confidence Interval () 95%
-0.77 to -0.43
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis p-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.34
Confidence Interval () 95%
-0.51 to -0.16
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Description Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 211 214 210 0 0
Least Squares Mean (Standard Error) [Percentage point of total HbA1c]
-1.29
(0.07)
-1.51
(0.07)
-0.88
(0.07)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis p-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated Treatment Difference, LS Mean
Estimated Value -0.63
Confidence Interval () 95%
-0.81 to -0.44
Parameter Dispersion Type:
Value:
Estimation Comments Lira 1.8 - Sita
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis p-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated Treatment Difference, LS Mean
Estimated Value -0.40
Confidence Interval () 95%
-0.59 to -0.22
Parameter Dispersion Type:
Value:
Estimation Comments Lira 1.2 - Sita
3. Primary Outcome
Title Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Description Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Time Frame Week 0, Week 78

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 211 214 0 0 0
Least Squares Mean (Standard Error) [Percentage point of total HbA1c]
-0.94
(0.08)
-1.28
(0.07)
4. Primary Outcome
Title Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Description Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 67 68
Mean (Standard Deviation) [Percentage point of total HbA1c]
-0.24
(0.7)
-0.45
(0.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita -> Sita -> Lira 1.2 mg
Comments The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0060
Comments Multiple comparisons is not applicable.
Method paired t-test
Comments The analysis is not a controlled comparison, and there are no adjustments
Method of Estimation Estimation Parameter Change within treatment group
Estimated Value -0.24
Confidence Interval () 95%
-0.41 to -0.07
Parameter Dispersion Type: Standard Deviation
Value: 0.7
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sita -> Sita -> Lira 1.8 mg
Comments The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0001
Comments Multiple comparisons is not applicable.
Method paired t-test
Comments The analysis is not a controlled comparison, and there are no adjustments
Method of Estimation Estimation Parameter Change within treatment group
Estimated Value -0.45
Confidence Interval () 95%
-0.67 to -0.23
Parameter Dispersion Type: Standard Deviation
Value: 0.9
Estimation Comments
5. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Description Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 218 219 0 0
Number [percentage of subjects]
43
55
22
6. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 211 214 210 0 0
Number [percentage of subjects]
50
63
27
7. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.
Time Frame Week 0, Week 78

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 211 214 0 0 0
Number [percentage of subjects]
35
51
8. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.
Time Frame Week 0, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 67 68
Number [percentage of subjects]
49
50
9. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Description Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 218 219 0 0
Number [percentage of subjects]
23
36
12
10. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 211 214 210 0 0
Number [percentage of subjects]
24
40
17
11. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.
Time Frame Week 0, Week 78

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 211 214 0 0 0
Number [percentage of subjects]
12
27
12. Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.
Time Frame Week 0, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 67 68
Number [percentage of subjects]
29
25
13. Secondary Outcome
Title Mean Change From Baseline in Body Weight at Week 26
Description Calculated as an estimate of the mean change from baseline in body weight at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 215 214 215 0 0
Least Squares Mean (Standard Error) [kg]
-2.86
(0.27)
-3.38
(0.27)
-0.96
(0.27)
14. Secondary Outcome
Title Mean Change From Baseline in Body Weight at Week 52
Description Calculated as an estimate of the mean change from baseline in body weight at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 215 214 215 0 0
Least Squares Mean (Standard Error) [kg]
-2.78
(0.31)
-3.68
(0.31)
-1.16
(0.31)
15. Secondary Outcome
Title Mean Change in Body Weight From Week 52 to Week 78
Description Mean change in body weight from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 67 68
Mean (Standard Deviation) [kg]
-1.64
(3)
-2.48
(3.6)
16. Secondary Outcome
Title Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Description Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 210 212 210 0 0
Least Squares Mean (Standard Error) [mmol/L]
-1.87
(0.15)
-2.14
(0.15)
-0.83
(0.15)
17. Secondary Outcome
Title Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Description Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 210 212 209 0 0
Least Squares Mean (Standard Error) [mmol/L]
-1.71
(0.17)
-2.04
(0.17)
-0.59
(0.17)
18. Secondary Outcome
Title Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Description Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
Time Frame Week 0, Week 78

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 210 212 0 0 0
Least Squares Mean (Standard Error) [mmol/L]
-1.30
(0.18)
-1.65
(0.18)
19. Secondary Outcome
Title Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Description Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 65 67
Mean (Standard Deviation) [mmol/L]
-0.84
(1.8)
-1.42
(2.1)
20. Secondary Outcome
Title Mean Change From Baseline in Beta-cell Function at Week 26
Description Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 196 208 201 0 0
Least Squares Mean (Standard Error) [percentage point]
27.23
(3.82)
28.70
(3.75)
4.18
(3.79)
21. Secondary Outcome
Title Mean Change From Baseline in Beta-cell Function at Week 52
Description Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 196 208 200 0 0
Least Squares Mean (Standard Error) [percentage point]
22.58
(3.31)
25.76
(3.25)
3.98
(3.30)
22. Secondary Outcome
Title Mean Change in Beta-cell Function From Week 52 to Week 78
Description Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 64 64
Mean (Standard Deviation) [percentage point]
13.31
(29.4)
23.09
(43.7)
23. Secondary Outcome
Title Mean Change From Baseline in Total Cholesterol at Week 26
Description Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 194 202 201 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.03
(0.06)
-0.17
(0.05)
-0.02
(0.05)
24. Secondary Outcome
Title Mean Change From Baseline in Total Cholesterol at Week 52
Description Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 195 203 200 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.01
(0.06)
-0.09
(0.06)
0.03
(0.06)
25. Secondary Outcome
Title Mean Change in Total Cholesterol From Week 52 to Week 78
Description Mean change in total cholesterol from Week 52 to Week 78
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 65 67
Mean (Standard Deviation) [mmol/L]
-0.16
(0.8)
-0.24
(0.7)
26. Secondary Outcome
Title Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
Description Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 194 202 200 0 0
Least Squares Mean (Standard Error) [mmol/L]
0.08
(0.05)
0.05
(0.05)
0.13
(0.05)
27. Secondary Outcome
Title Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
Description Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 195 203 199 0 0
Least Squares Mean (Standard Error) [mmol/L]
0.09
(0.05)
0.09
(0.05)
0.17
(0.05)
28. Secondary Outcome
Title Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
Description Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 65 67
Mean (Standard Deviation) [mmol/L]
-0.22
(0.7)
-0.25
(0.6)
29. Secondary Outcome
Title Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
Description Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 194 201 201 0 0
Least Squares Mean (Standard Error) [mmol/L]
0.00
(0.01)
0.00
(0.01)
0.00
(0.01)
30. Secondary Outcome
Title Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
Description Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 195 202 200 0 0
Least Squares Mean (Standard Error) [mmol/L]
0.01
(0.01)
0.02
(0.01)
0.01
(0.01)
31. Secondary Outcome
Title Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
Description Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 65 67
Mean (Standard Deviation) [mmol/L]
0.02
(0.1)
-0.01
(0.2)
32. Secondary Outcome
Title Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
Description Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 194 201 199 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.11
(0.03)
-0.20
(0.03)
-0.15
(0.03)
33. Secondary Outcome
Title Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
Description Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 195 202 198 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.11
(0.04)
-0.19
(0.04)
-0.15
(0.04)
34. Secondary Outcome
Title Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
Description Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 65 67
Mean (Standard Deviation) [mmol/L]
0.03
(0.3)
0.02
(0.3)
35. Secondary Outcome
Title Mean Change From Baseline in Triglycerides (TG) at Week 26
Description Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 191 199 198 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.19
(0.10)
-0.43
(0.09)
-0.40
(0.09)
36. Secondary Outcome
Title Mean Change From Baseline in Triglycerides (TG) at Week 52
Description Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 194 200 197 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.10
(0.10)
-0.32
(0.10)
-0.23
(0.10)
37. Secondary Outcome
Title Mean Change in Triglycerides (TG) From Week 52 to Week 78
Description Mean change in triglycerides (TG) from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 64 66
Mean (Standard Deviation) [mmol/L]
-0.20
(0.8)
-0.26
(0.8)
38. Secondary Outcome
Title Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
Description Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 147 149 158 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.03
(0.02)
-0.07
(0.02)
-0.05
(0.02)
39. Secondary Outcome
Title Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
Description Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 170 177 176 0 0
Least Squares Mean (Standard Error) [mmol/L]
-0.07
(0.02)
-0.10
(0.02)
-0.06
(0.02)
40. Secondary Outcome
Title Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
Description Mean change in free fatty acids (FFA) from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 60 65
Mean (Standard Deviation) [mmol/L]
0.02
(0.3)
-0.01
(0.3)
41. Secondary Outcome
Title Mean Change From Baseline in Apolipoprotein B at Week 26
Description Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 164 175 182 0 0
Least Squares Mean (Standard Error) [g/L]
-0.06
(0.01)
-0.07
(0.01)
-0.05
(0.01)
42. Secondary Outcome
Title Mean Change From Baseline in Apolipoprotein B at Week 52
Description Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 184 192 195 0 0
Least Squares Mean (Standard Error) [g/L]
-0.03
(0.01)
-0.03
(0.01)
-0.03
(0.01)
43. Secondary Outcome
Title Mean Change in Apolipoprotein B From Week 52 to Week 78
Description Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 66 68
Mean (Standard Deviation) [mmol/L]
0.23
(0.4)
0.17
(0.4)
44. Secondary Outcome
Title Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
Description Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 205 209 205 0 0
Least Squares Mean (Standard Error) [mg/L]
-1.02
(0.31)
-0.99
(0.31)
-0.66
(0.31)
45. Secondary Outcome
Title Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
Description Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 188 198 182 0 0
Least Squares Mean (Standard Error) [U/L]
-833
(945.1)
-561
(941.1)
586
(952)
46. Secondary Outcome
Title Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
Description Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 204 210 206 0 0
Least Squares Mean (Standard Error) [pg/mL]
-1.70
(2.49)
1.71
(2.47)
0.91
(2.49)
47. Secondary Outcome
Title Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Description Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 204 209 205 0 0
Least Squares Mean (Standard Error) [pmol/L]
5.19
(2.07)
3.74
(2.06)
3.71
(2.07)
48. Secondary Outcome
Title Mean Change From Baseline in Adiponectin at Week 26.
Description Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 202 210 207 0 0
Least Squares Mean (Standard Error) [mcg/mL]
1.69
(0.19)
1.51
(0.19)
1.35
(0.19)
49. Secondary Outcome
Title Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Description Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 195 204 196 0 0
Least Squares Mean (Standard Error) [pg/mL]
-0.55
(0.25)
-0.74
(0.25)
-0.53
(0.25)
50. Secondary Outcome
Title Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
Description Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 189 193 183 0 0
Least Squares Mean (Standard Error) [percentage point]
-1.73
(2.77)
-4.34
(2.76)
-1.8
(2.82)
51. Secondary Outcome
Title Mean Change From Baseline in Waist to Hip Ratio at Week 26.
Description Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 210 208 207 0 0
Least Squares Mean (Standard Error) [cm/cm]
-0.01
(0.00)
-0.01
(0.00)
-0.00
(0.00)
52. Secondary Outcome
Title Mean Change From Baseline in Waist to Hip Ratio at Week 52
Description Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 210 208 207 0 0
Least Squares Mean (Standard Error) [cm/cm]
-0.00
(0.00)
-0.01
(0.00)
-0.00
(0.00)
53. Secondary Outcome
Title Mean Change in Waist to Hip Ratio From Week 52 to Week 78
Description Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 66 67
Mean (Standard Deviation) [cm/cm]
-0.01
(0)
-0.00
(0)
54. Secondary Outcome
Title Mean Change From Baseline in Waist Circumference at Week 26.
Description Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 210 208 208 0 0
Least Squares Mean (Standard Error) [cm]
-2.69
(0.35)
-2.63
(0.36)
-1.12
(0.36)
55. Secondary Outcome
Title Mean Change From Baseline in Waist Circumference at Week 52
Description Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 210 208 208 0 0
Least Squares Mean (Standard Error) [participants]
-2.36
(0.38) -1%
-3.02
(0.38) -1.4%
-1.23
(0.38) -0.6%
56. Secondary Outcome
Title Mean Change in Waist Circumference From Week 52 to Week 78
Description Mean change in Waist Circumference from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 66 68
Mean (Standard Deviation) [kg]
-1.33
(3.5)
-2.05
(4.1)
57. Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Description Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 213 214 213 0 0
Least Squares Mean (Standard Error) [mmHg]
-0.55
(0.89)
-0.72
(0.89)
-0.94
(0.89)
58. Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Description Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 213 214 213 0 0
Least Squares Mean (Standard Error) [mmHg]
-0.37
(0.93)
-2.55
(0.93)
-1.03
(0.93)
59. Secondary Outcome
Title Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
Description Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 67 68
Mean (Standard Deviation) [mmHg]
-2.12
(14.6)
0.35
(12.4)
60. Secondary Outcome
Title Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Description Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 213 214 213 0 0
Least Squares Mean (Standard Error) [mmHg]
-0.71
(0.60)
0.07
(0.59)
-1.78
(0.60)
61. Secondary Outcome
Title Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
Description Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 213 214 213 0 0
Least Squares Mean (Standard Error) [mmHg]
-0.53
(0.57)
-0.87
(0.57)
-1.47
(0.57)
62. Secondary Outcome
Title Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
Description Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 67 68
Mean (Standard Deviation) [mmHg]
-0.60
(10.0)
0.03
(8.9)
63. Secondary Outcome
Title Mean Change From Baseline in Pulse at Week 26
Description Calculated as an estimate of the mean change from baseline in pulse at Week 26.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 212 214 211 0 0
Least Squares Mean (Standard Error) [beats/minute]
2.32
(0.59)
3.94
(0.58)
-0.64
(0.59)
64. Secondary Outcome
Title Mean Change From Baseline in Pulse at Week 52
Description Calculated as an estimate of the mean change from baseline in pulse at Week 52.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 212 214 211 0 0
Least Squares Mean (Standard Error) [mmHg]
1.72
(0.60)
3.09
(0.60)
0.09
(0.60)
65. Secondary Outcome
Title Mean Change in Pulse From Week 52 to Week 78
Description Mean change in pulse from Week 52 to Week 78.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 67 68
Mean (Standard Deviation) [beats/minute]
0.90
(8.4)
2.19
(7.7)
66. Secondary Outcome
Title Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
Description The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 164 171 170 0 0
Least Squares Mean (Standard Error) [scores on a scale]
3.51
(0.49)
4.35
(0.48)
2.96
(0.48)
67. Secondary Outcome
Title Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
Description The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time Frame Week 0, Week 52

Outcome Measure Data

Analysis Population Description
Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 163 165 169 0 0
Least Squares Mean (Standard Error) [scores on a scale]
3.32
(0.49)
4.31
(0.48)
2.96
(0.48)
68. Secondary Outcome
Title Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
Description The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time Frame Week 52, Week 78

Outcome Measure Data

Analysis Population Description
Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 0 0 0 54 48
Mean (Standard Deviation) [scores on a scale]
1.48
(4.4)
0.98
(6.1)
69. Secondary Outcome
Title Hypoglyceamic Episodes, Weeks 0-26
Description Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Weeks 0-26

Outcome Measure Data

Analysis Population Description
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 218 219 0 0
Major
1
0
0
Minor
17
37
11
Symptoms only
12
15
10
Unclassified
0
1
0
70. Secondary Outcome
Title Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Description Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Weeks 0-26

Outcome Measure Data

Analysis Population Description
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 217 219 0 0
Major
1
0
0
Minor
17
16
11
Symptoms only
12
15
10
Unclassified
0
1
0
71. Secondary Outcome
Title Hypoglyceamic Episodes, Weeks 0-52
Description Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Weeks 0-52

Outcome Measure Data

Analysis Population Description
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 218 219 0 0
Major
1
0
0
Minor
24
51
25
Symptoms only
14
29
12
Unclassified
0
1
0
72. Secondary Outcome
Title Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Description Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Weeks 0-52

Outcome Measure Data

Analysis Population Description
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 218 219 0 0
Major
1
0
0
Minor
24
28
25
Symptoms only
14
29
12
Unclassified
0
1
0
73. Secondary Outcome
Title Hypoglyceamic Episodes, Weeks 0-78
Description Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Weeks 0-78

Outcome Measure Data

Analysis Population Description
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 218 219 0 0
Major
2
0
0
Minor
36
56
34
Symptoms only
18
40
13
Unclassified
0
1
0
74. Secondary Outcome
Title Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Description Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Weeks 0-78

Outcome Measure Data

Analysis Population Description
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 221 218 219 0 0
Major
2
0
0
Minor
36
33
34
Symptoms only
18
40
13
Unclassified
0
1
0
75. Secondary Outcome
Title Hypoglycaamic Episodes, Weeks 52-78
Description Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Week 52-78

Outcome Measure Data

Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Measure Participants 134 150 0 67 68
Major
1
0
0
0
Minor
12
5
3
6
Symptoms only
3
11
1
0
Unclassified
0
0
0
0

Adverse Events

Time Frame The adverse events were collected in a timeframe of 78 weeks.
Adverse Event Reporting Description The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita
Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
All Cause Mortality
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 12/221 (5.4%) 19/218 (8.7%) 17/219 (7.8%)
Blood and lymphatic system disorders
Haemorrhagic anaemia 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Cardiac disorders
Cardiac failure 0/221 (0%) 0 2/218 (0.9%) 2 0/219 (0%) 0
Cardiac arrest 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Angina pectoris 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Myocardial ischaemia 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Acute myocardial infarction 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Arrhythmia 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Myocardial infarction 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Congenital, familial and genetic disorders
Hereditary haemorrhagic telangiectasia 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Endocrine disorders
Thyroid disorder 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Eye disorders
Diabetic retinopathy 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Papilloedema 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Gastrointestinal disorders
Colonic polyp 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Pancreatitis 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Peritonitis 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Subileus 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Haematochezia 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Inguinal hernia 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
General disorders
Non-cardiac chest pain 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Hypothermia 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Sudden cardiac death 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Hepatobiliary disorders
Bile duct stenosis 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Cholangitis acute 0/221 (0%) 0 1/218 (0.5%) 2 0/219 (0%) 0
Cholecystitis acute 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Infections and infestations
Mycetoma mycotic 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Infected sebaceous cyst 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Abcess Limb 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Cellulitis 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Cholecytitis infective 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Pneumonia 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Sepsis 0/221 (0%) 0 1/218 (0.5%) 1 1/219 (0.5%) 1
Anal abscess 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Appendicitis 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Dengue fever 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Gastroenteritis 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Urinary tract infection 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Injury, poisoning and procedural complications
Subdural haematoma 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Fall 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Femur fracture 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Meniscus lesion 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Metabolism and nutrition disorders
Dehydration 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Hypoglycaemia 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Musculoskeletal and connective tissue disorders
Osteoarthritis 2/221 (0.9%) 2 0/218 (0%) 0 0/219 (0%) 0
Sympathetic posterior cervical syndrome 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Rotator cuff syndrome 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Epiglottic carcinoma 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Renal cancer 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Bile duct cancer 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Breast cancer 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Colon cancer 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Renal adenoma 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Nervous system disorders
Hypoaesthesia 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Psychiatric disorders
Mental status changes 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Renal and urinary disorders
Nephrolithiasis 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Renal failure acute 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Reproductive system and breast disorders
Postmenopausal haemorrhage 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Benign prostatic hyperplasia 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Respiratory, thoracic and mediastinal disorders
Epistaxis 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Dyspnoea 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Sleep apnoe syndrome 0/221 (0%) 0 0/218 (0%) 0 1/219 (0.5%) 1
Surgical and medical procedures
Hip arthroplasty 0/221 (0%) 0 1/218 (0.5%) 1 0/219 (0%) 0
Vascular disorders
Hypertensive crisis 1/221 (0.5%) 1 0/218 (0%) 0 0/219 (0%) 0
Other (Not Including Serious) Adverse Events
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 120/221 (54.3%) 134/218 (61.5%) 106/219 (48.4%)
Gastrointestinal disorders
Nausea 48/221 (21.7%) 60 61/218 (28%) 73 36/219 (16.4%) 45
Diarrhoea 21/221 (9.5%) 30 29/218 (13.3%) 52 24/219 (11%) 40
Vomiting 18/221 (8.1%) 27 24/218 (11%) 28 15/219 (6.8%) 21
Dyspepsia 8/221 (3.6%) 9 17/218 (7.8%) 23 11/219 (5%) 17
Constipation 10/221 (4.5%) 11 14/218 (6.4%) 16 10/219 (4.6%) 11
General disorders
Fatigue 9/221 (4.1%) 9 13/218 (6%) 14 5/219 (2.3%) 5
Infections and infestations
Nasopharyngitis 33/221 (14.9%) 42 36/218 (16.5%) 52 32/219 (14.6%) 50
Influenza 14/221 (6.3%) 17 7/218 (3.2%) 7 9/219 (4.1%) 13
Upper respiratory tract infection 16/221 (7.2%) 27 11/218 (5%) 16 14/219 (6.4%) 20
Investigations
Blood calcitonin increased 9/221 (4.1%) 9 11/218 (5%) 14 6/219 (2.7%) 7
Metabolism and nutrition disorders
Decreased appetite 8/221 (3.6%) 8 12/218 (5.5%) 12 9/219 (4.1%) 9
Musculoskeletal and connective tissue disorders
Back pain 13/221 (5.9%) 21 14/218 (6.4%) 16 13/219 (5.9%) 16
Nervous system disorders
Headache 23/221 (10.4%) 36 31/218 (14.2%) 56 33/219 (15.1%) 50
Dizziness 10/221 (4.5%) 10 14/218 (6.4%) 19 8/219 (3.7%) 8
Vascular disorders
Hypertension 13/221 (5.9%) 13 14/218 (6.4%) 14 7/219 (3.2%) 8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.

Results Point of Contact

Name/Title Public Access to Clinical Trials
Organization Novo Nordisk A/S
Phone
Email clinicaltrials@novonordisk.com
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00700817
Other Study ID Numbers:
  • NN2211-1860
  • 2007-003937-17
First Posted:
Jun 19, 2008
Last Update Posted:
Mar 8, 2017
Last Verified:
Jan 1, 2017