LIRA-PRIME: Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02730377
Collaborator
(none)
1,991
232
2
40.5
8.6
0.2

Study Details

Study Description

Brief Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1991 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy and Treated in a Primary Care Setting
Actual Study Start Date :
Mar 28, 2016
Actual Primary Completion Date :
Aug 5, 2019
Actual Study Completion Date :
Aug 12, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liraglutide 1.8 mg

Add-on to metformin

Drug: liraglutide
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Active Comparator: OAD

Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.

Drug: alpha-glucosidase inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: DPP-4 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: meglitinides
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: SGLT-2 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: sulphonylurea
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: thiazolidinediones
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Outcome Measures

Primary Outcome Measures

  1. Time to Inadequate Glycaemic Control [Weeks 26-104]

    Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104.

Secondary Outcome Measures

  1. Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) [Weeks 0-104]

    The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function.

  2. Change in HbA1c [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented.

  3. Participants Who Achieve HbA1c ≤6.5% (Yes/No) [Week 104/Premature treatment discontinuation]

    Participants who achieved HbA1c ≤6.5% (yes/no) is presented.

  4. Participants Who Achieve HbA1c ≤7.0% Without Weight Gain [Week 104/Premature treatment discontinuation]

    Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented.

  5. Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes [Week 104/Premature treatment discontinuation]

    Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.

  6. Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes [Week 104/Premature treatment discontinuation]

    Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.

  7. Change in Fasting Plasma Glucose (FPG) [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented.

  8. Change in Body Weight [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented.

  9. Change in Body Mass Index (BMI) [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented.

  10. Change in Blood Pressure (Systolic and Diastolic Blood Pressure) [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented.

  11. Number of Severe Hypoglycaemic Episodes [Weeks 0-104]

    Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented.

  12. Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [Weeks 0-104]

    Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented.

  13. Number of Documented Symptomatic Hypoglycaemic Episodes (ADA) [Weeks 0-104]

    Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration <= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented.

  14. Number of Serious Adverse Events (SAEs) [Weeks 0-105]

    A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented.

  15. Number of AEs Leading to Permanent Discontinuation of Trial Product [Weeks 0-105]

    An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented.

  16. Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented.

  17. Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented.

  18. Change in Biochemistry- Creatinine, Total Bilirubin [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented.

  19. Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum [Week 0, week 104/premature treatment discontinuation]

    The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA).

  20. Change in Potassium [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented.

  21. Change in Haemoglobin [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented.

  22. Change in Pulse [Week 0, week 104/premature treatment discontinuation]

    Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria: - Male or female at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Contacts and Locations

Locations

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222 Novo Nordisk Investigational Site Moscow Russian Federation 121293
223 Novo Nordisk Investigational Site Moscow Russian Federation 125315
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225 Novo Nordisk Investigational Site Belgrade Serbia 11000
226 Novo Nordisk Investigational Site Kragujevac Serbia 34000
227 Novo Nordisk Investigational Site Nis Serbia 18000
228 Novo Nordisk Investigational Site Novi Sad Serbia 21000
229 Novo Nordisk Investigational Site Adapazari Turkey 54290
230 Novo Nordisk Investigational Site Istanbul Turkey 34130
231 Novo Nordisk Investigational Site Istanbul Turkey 34722
232 Novo Nordisk Investigational Site Istanbul Turkey 34890

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02730377
Other Study ID Numbers:
  • NN2211-4232
  • 2015-002417-29
  • U1111-1170-7035
First Posted:
Apr 6, 2016
Last Update Posted:
Jul 7, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details The trial was conducted at 219 sites in Canada (11), Colombia (3), India (16), Latvia (2), Lebanon (4), Russian Federation (5), Serbia (6), Turkey (4) and the United States (168).
Pre-assignment Detail Participants were randomised in a 1:1 manner to receive either liraglutide or an oral antidiabetic drug (OAD) both as add-on to background therapy with metformin.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Period Title: Overall Study
STARTED 996 995
Treated 980 984
Full Analysis Set (FAS) 996 995
Safety Analysis Set (SAS) 980 984
COMPLETED 446 362
NOT COMPLETED 550 633

Baseline Characteristics

Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug Total
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. Total of all reporting groups
Overall Participants 996 995 1991
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
57.6
(11.0)
57.1
(10.7)
57.4
(10.8)
Sex: Female, Male (Count of Participants)
Female
476
47.8%
471
47.3%
947
47.6%
Male
520
52.2%
524
52.7%
1044
52.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
176
17.7%
189
19%
365
18.3%
Not Hispanic or Latino
820
82.3%
806
81%
1626
81.7%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native
3
0.3%
6
0.6%
9
0.5%
Asian
149
15%
141
14.2%
290
14.6%
Black or African American
101
10.1%
106
10.7%
207
10.4%
Native Hawaiian or Other Pacific Islander
3
0.3%
2
0.2%
5
0.3%
White
724
72.7%
714
71.8%
1438
72.2%
Other
16
1.6%
26
2.6%
42
2.1%

Outcome Measures

1. Primary Outcome
Title Time to Inadequate Glycaemic Control
Description Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104.
Time Frame Weeks 26-104

Outcome Measure Data

Analysis Population Description
FAS included all randomised participants. Overall number of participants analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 416 547
Median (Inter-Quartile Range) [Weeks]
108.9
64.9
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Oral Antidiabetic Drug
Comments Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <.0001
Comments
Method Log Rank
Comments
2. Secondary Outcome
Title Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)
Description The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function.
Time Frame Weeks 0-104

Outcome Measure Data

Analysis Population Description
FAS included all randomised participants. Overall number of participants analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 532 624
Median (Inter-Quartile Range) [Weeks]
80.4
52.3
3. Secondary Outcome
Title Change in HbA1c
Description Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Change at week 104
-1.4
(1.06)
-1.1
(1.04)
Change at premature treatment discontinuation
-0.6
(1.03)
-0.2
(1.56)
4. Secondary Outcome
Title Participants Who Achieve HbA1c ≤6.5% (Yes/No)
Description Participants who achieved HbA1c ≤6.5% (yes/no) is presented.
Time Frame Week 104/Premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
FAS included all randomised participants.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Yes
255
25.6%
162
16.3%
No
741
74.4%
833
83.7%
5. Secondary Outcome
Title Participants Who Achieve HbA1c ≤7.0% Without Weight Gain
Description Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented.
Time Frame Week 104/Premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
FAS included all randomised participants.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Yes
329
33%
234
23.5%
No
667
67%
761
76.5%
6. Secondary Outcome
Title Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes
Description Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.
Time Frame Week 104/Premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
FAS included all randomised participants.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Yes
388
39%
292
29.3%
No
608
61%
703
70.7%
7. Secondary Outcome
Title Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Description Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.
Time Frame Week 104/Premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
FAS included all randomised participants.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Yes
320
32.1%
227
22.8%
No
676
67.9%
768
77.2%
8. Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Description Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Change at week 104
-2.2
(2.65)
-1.2
(2.46)
Change at premature treatment discontinuation
-0.6
(2.91)
-0.6
(3.76)
9. Secondary Outcome
Title Change in Body Weight
Description Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Change at week 104
-3.8
(6.38)
-3.5
(6.19)
Change at premature treatment discontinuation
-2.9
(3.74)
-2.2
(4.93)
10. Secondary Outcome
Title Change in Body Mass Index (BMI)
Description Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
Change at week 104
-1.3
(2.26)
-1.2
(2.14)
Change at premature treatment discontinuation
-1.1
(1.33)
-0.8
(1.71)
11. Secondary Outcome
Title Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Description Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 996 995
SBP: Change at week 104
-2.4
(15.09)
-1.1
(15.11)
SBP: Change at premature treatment discontinuation
-2.8
(15.99)
-2.9
(15.23)
DBP: Change at week 104
-1.3
(9.51)
-0.6
(9.54)
DBP: Change at premature treatment discontinuation
-1.0
(11.27)
0.2
(9.69)
12. Secondary Outcome
Title Number of Severe Hypoglycaemic Episodes
Description Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented.
Time Frame Weeks 0-104

Outcome Measure Data

Analysis Population Description
Safety analysis set (SAS) included all participants exposed to at least one dose of trial product.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Number [Episodes]
32
52
13. Secondary Outcome
Title Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Description Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented.
Time Frame Weeks 0-104

Outcome Measure Data

Analysis Population Description
SAS included all participants exposed to at least one dose of trial product.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Number [Episodes]
24
44
14. Secondary Outcome
Title Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)
Description Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration <= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented.
Time Frame Weeks 0-104

Outcome Measure Data

Analysis Population Description
SAS included all participants exposed to at least one dose of trial product.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Number [Episodes]
98
155
15. Secondary Outcome
Title Number of Serious Adverse Events (SAEs)
Description A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented.
Time Frame Weeks 0-105

Outcome Measure Data

Analysis Population Description
SAS included all participants exposed to at least one dose of trial product.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Number [Events]
145
140
16. Secondary Outcome
Title Number of AEs Leading to Permanent Discontinuation of Trial Product
Description An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented.
Time Frame Weeks 0-105

Outcome Measure Data

Analysis Population Description
SAS included all participants exposed to at least one dose of trial product.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Number [Events]
188
98
17. Secondary Outcome
Title Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides
Description Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
HDL: Change at week 104
0.1
(0.20)
0.1
(0.19)
HDL: Change at premature treatment discontinuation
-0.0
(0.17)
0.0
(0.20)
LDL: Change at week 104
-0.1
(0.80)
0.0
(0.83)
LDL: Change at premature treatment discontinuation
-0.1
(0.68)
-0.1
(0.85)
TC: Change at week 104
-0.2
(0.92)
0.1
(0.99)
TC: Change at premature treatment discontinuation
-0.0
(0.81)
-0.1
(0.96)
TG: Change at week 104
-0.3
(0.95)
-0.1
(1.25)
TG: Change at premature treatment discontinuation
-0.0
(1.13)
-0.0
(1.30)
18. Secondary Outcome
Title Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase
Description Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
ALAT: Week 104
-4.6
(17.83)
-5.4
(17.13)
ALAT: Premature treatment discontinuation
-3.2
(12.44)
-3.3
(14.67)
Amylase: Week 104
8.9
(30.93)
5.1
(26.30)
Amylase: Premature treatment discontinuation
0.6
(23.61)
2.1
(17.92)
ASAT: Week 104
-2.0
(13.27)
-2.3
(11.85)
ASAT: Premature treatment discontinuation
-1.9
(10.76)
-0.4
(11.64)
Lipase: Week 104
15.1
(67.69)
-0.5
(50.03)
Lipase: Premature treatment discontinuation
10.4
(32.40)
-2.2
(35.79)
19. Secondary Outcome
Title Change in Biochemistry- Creatinine, Total Bilirubin
Description Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Creatinine: week 104
3.3
(13.37)
1.0
(12.86)
Creatinine: premature treatment discontinuation
2.9
(12.06)
2.6
(21.13)
TB: week 104
0.4
(4.47)
0.7
(3.80)
TB: premature treatment discontinuation
-0.0
(2.78)
-0.6
(3.17)
20. Secondary Outcome
Title Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum
Description The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA).
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Change at week 104
-5.1
(20.33)
-1.6
(16.29)
Change at premature treatment discontinuation
-3.0
(12.56)
-1.7
(15.01)
21. Secondary Outcome
Title Change in Potassium
Description Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Change at week 104
-0.1
(0.60)
-0.0
(0.59)
Change at premature treatment discontinuation
-0.0
(0.44)
-0.2
(0.71)
22. Secondary Outcome
Title Change in Haemoglobin
Description Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Change at week 104
-0.4
(1.07)
-0.0
(1.16)
Change at premature treatment discontinuation
-0.3
(0.87)
-0.3
(1.12)
23. Secondary Outcome
Title Change in Pulse
Description Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented.
Time Frame Week 0, week 104/premature treatment discontinuation

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
Measure Participants 980 984
Change at week 104
1.0
(10.25)
-0.6
(10.23)
Change at premature treatment discontinuation
0.7
(9.84)
0.9
(10.59)

Adverse Events

Time Frame Weeks 0-105
Adverse Event Reporting Description All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants exposed to at least one dose of trial product.
Arm/Group Title Liraglutide 1.8 mg Oral Antidiabetic Drug
Arm/Group Description Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
All Cause Mortality
Liraglutide 1.8 mg Oral Antidiabetic Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/980 (0.1%) 8/984 (0.8%)
Serious Adverse Events
Liraglutide 1.8 mg Oral Antidiabetic Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 92/980 (9.4%) 81/984 (8.2%)
Blood and lymphatic system disorders
Anaemia 1/980 (0.1%) 1 2/984 (0.2%) 2
Blood loss anaemia 0/980 (0%) 0 1/984 (0.1%) 1
Iron deficiency anaemia 1/980 (0.1%) 1 1/984 (0.1%) 1
Leukocytosis 0/980 (0%) 0 1/984 (0.1%) 1
Cardiac disorders
Acute myocardial infarction 5/980 (0.5%) 5 6/984 (0.6%) 6
Angina pectoris 4/980 (0.4%) 4 1/984 (0.1%) 1
Angina unstable 0/980 (0%) 0 1/984 (0.1%) 1
Arrhythmia supraventricular 1/980 (0.1%) 1 0/984 (0%) 0
Arteriosclerosis coronary artery 1/980 (0.1%) 1 1/984 (0.1%) 1
Atrial fibrillation 3/980 (0.3%) 3 2/984 (0.2%) 2
Atrioventricular block second degree 0/980 (0%) 0 1/984 (0.1%) 1
Cardiac failure 0/980 (0%) 0 1/984 (0.1%) 1
Cardiac failure congestive 3/980 (0.3%) 4 4/984 (0.4%) 4
Cardiomyopathy 1/980 (0.1%) 1 1/984 (0.1%) 1
Cardiovascular disorder 1/980 (0.1%) 1 0/984 (0%) 0
Coronary artery disease 1/980 (0.1%) 1 2/984 (0.2%) 2
Coronary artery stenosis 1/980 (0.1%) 1 0/984 (0%) 0
Mitral valve incompetence 0/980 (0%) 0 1/984 (0.1%) 1
Myocardial infarction 0/980 (0%) 0 2/984 (0.2%) 2
Myocardial ischaemia 1/980 (0.1%) 1 0/984 (0%) 0
Ventricular fibrillation 1/980 (0.1%) 1 0/984 (0%) 0
Ear and labyrinth disorders
Vertigo positional 1/980 (0.1%) 1 0/984 (0%) 0
Endocrine disorders
Empty sella syndrome 1/980 (0.1%) 1 0/984 (0%) 0
Eye disorders
Cataract 1/980 (0.1%) 1 0/984 (0%) 0
Exophthalmos 1/980 (0.1%) 1 0/984 (0%) 0
Gastrointestinal disorders
Abdominal pain lower 0/980 (0%) 0 1/984 (0.1%) 1
Chronic gastritis 0/980 (0%) 0 1/984 (0.1%) 1
Colitis ischaemic 1/980 (0.1%) 1 0/984 (0%) 0
Constipation 1/980 (0.1%) 1 0/984 (0%) 0
Duodenal stenosis 1/980 (0.1%) 1 0/984 (0%) 0
Enteritis 0/980 (0%) 0 1/984 (0.1%) 1
Erosive duodenitis 0/980 (0%) 0 1/984 (0.1%) 1
Gastric ulcer 0/980 (0%) 0 1/984 (0.1%) 1
Gastrointestinal haemorrhage 0/980 (0%) 0 2/984 (0.2%) 2
Gastrooesophageal reflux disease 0/980 (0%) 0 1/984 (0.1%) 1
Hiatus hernia 0/980 (0%) 0 2/984 (0.2%) 2
Impaired gastric emptying 1/980 (0.1%) 1 0/984 (0%) 0
Oesophageal obstruction 1/980 (0.1%) 1 0/984 (0%) 0
Oesophageal varices haemorrhage 0/980 (0%) 0 1/984 (0.1%) 1
Oesophagitis 1/980 (0.1%) 1 0/984 (0%) 0
Pancreatitis 1/980 (0.1%) 1 1/984 (0.1%) 1
Pancreatitis acute 1/980 (0.1%) 1 1/984 (0.1%) 1
Small intestinal obstruction 1/980 (0.1%) 2 0/984 (0%) 0
Vomiting 0/980 (0%) 0 1/984 (0.1%) 1
General disorders
Asthenia 1/980 (0.1%) 1 1/984 (0.1%) 1
Chest pain 4/980 (0.4%) 4 1/984 (0.1%) 1
Incarcerated hernia 1/980 (0.1%) 1 0/984 (0%) 0
Hepatobiliary disorders
Cholelithiasis 0/980 (0%) 0 2/984 (0.2%) 2
Hepatic cirrhosis 1/980 (0.1%) 1 1/984 (0.1%) 1
Hepatosplenomegaly 0/980 (0%) 0 1/984 (0.1%) 1
Portal hypertension 0/980 (0%) 0 1/984 (0.1%) 1
Infections and infestations
Bronchitis 1/980 (0.1%) 1 0/984 (0%) 0
Diverticulitis 1/980 (0.1%) 1 1/984 (0.1%) 1
Erysipelas 1/980 (0.1%) 1 0/984 (0%) 0
Fournier's gangrene 0/980 (0%) 0 1/984 (0.1%) 1
Gastroenteritis 1/980 (0.1%) 1 1/984 (0.1%) 1
Gastroenteritis viral 1/980 (0.1%) 1 0/984 (0%) 0
Influenza 1/980 (0.1%) 1 1/984 (0.1%) 1
Lower respiratory tract infection 0/980 (0%) 0 1/984 (0.1%) 1
Osteomyelitis 0/980 (0%) 0 1/984 (0.1%) 1
Pneumonia 4/980 (0.4%) 4 5/984 (0.5%) 5
Pneumonia influenzal 0/980 (0%) 0 1/984 (0.1%) 1
Pneumonia streptococcal 1/980 (0.1%) 1 0/984 (0%) 0
Postoperative wound infection 0/980 (0%) 0 1/984 (0.1%) 1
Pulmonary sepsis 1/980 (0.1%) 1 0/984 (0%) 0
Pyelonephritis acute 1/980 (0.1%) 1 0/984 (0%) 0
Rectal abscess 1/980 (0.1%) 1 0/984 (0%) 0
Scrotal abscess 0/980 (0%) 0 1/984 (0.1%) 1
Sepsis 0/980 (0%) 0 3/984 (0.3%) 3
Tonsillitis 1/980 (0.1%) 1 1/984 (0.1%) 1
Urinary tract infection 0/980 (0%) 0 1/984 (0.1%) 1
Urosepsis 1/980 (0.1%) 1 1/984 (0.1%) 1
Injury, poisoning and procedural complications
Ankle fracture 0/980 (0%) 0 1/984 (0.1%) 1
Arterial bypass occlusion 1/980 (0.1%) 1 0/984 (0%) 0
Concussion 0/980 (0%) 0 1/984 (0.1%) 1
Fall 1/980 (0.1%) 1 2/984 (0.2%) 2
Femur fracture 0/980 (0%) 0 2/984 (0.2%) 2
Gun shot wound 0/980 (0%) 0 1/984 (0.1%) 1
Hip fracture 1/980 (0.1%) 1 0/984 (0%) 0
Humerus fracture 0/980 (0%) 0 1/984 (0.1%) 1
Joint dislocation 1/980 (0.1%) 1 0/984 (0%) 0
Ligament rupture 1/980 (0.1%) 1 0/984 (0%) 0
Lower limb fracture 0/980 (0%) 0 1/984 (0.1%) 1
Lumbar vertebral fracture 0/980 (0%) 0 1/984 (0.1%) 1
Rib fracture 0/980 (0%) 0 1/984 (0.1%) 1
Road traffic accident 1/980 (0.1%) 1 1/984 (0.1%) 1
Spinal compression fracture 1/980 (0.1%) 1 0/984 (0%) 0
Wound 0/980 (0%) 0 1/984 (0.1%) 1
Investigations
Troponin increased 0/980 (0%) 0 1/984 (0.1%) 1
Metabolism and nutrition disorders
Dehydration 0/980 (0%) 0 1/984 (0.1%) 1
Diabetic ketoacidosis 0/980 (0%) 0 1/984 (0.1%) 1
Gout 0/980 (0%) 0 1/984 (0.1%) 1
Hyperglycaemia 1/980 (0.1%) 1 1/984 (0.1%) 1
Hyponatraemia 1/980 (0.1%) 1 1/984 (0.1%) 1
Lactic acidosis 0/980 (0%) 0 1/984 (0.1%) 1
Metabolic acidosis 1/980 (0.1%) 1 0/984 (0%) 0
Obesity 2/980 (0.2%) 2 1/984 (0.1%) 1
Musculoskeletal and connective tissue disorders
Back pain 0/980 (0%) 0 1/984 (0.1%) 1
Intervertebral disc degeneration 1/980 (0.1%) 1 0/984 (0%) 0
Intervertebral disc displacement 0/980 (0%) 0 1/984 (0.1%) 1
Intervertebral disc protrusion 2/980 (0.2%) 2 0/984 (0%) 0
Lumbar spinal stenosis 2/980 (0.2%) 2 0/984 (0%) 0
Musculoskeletal chest pain 1/980 (0.1%) 1 1/984 (0.1%) 1
Osteoarthritis 3/980 (0.3%) 3 1/984 (0.1%) 1
Spinal stenosis 1/980 (0.1%) 1 1/984 (0.1%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma 0/980 (0%) 0 1/984 (0.1%) 1
Bladder transitional cell carcinoma 1/980 (0.1%) 1 0/984 (0%) 0
Breast cancer 1/980 (0.1%) 1 0/984 (0%) 0
Colorectal cancer metastatic 1/980 (0.1%) 1 0/984 (0%) 0
Gastrointestinal tract adenoma 1/980 (0.1%) 1 0/984 (0%) 0
Invasive ductal breast carcinoma 1/980 (0.1%) 1 1/984 (0.1%) 1
Lung adenocarcinoma 0/980 (0%) 0 1/984 (0.1%) 1
Lung adenocarcinoma stage IV 0/980 (0%) 0 1/984 (0.1%) 1
Lung cancer metastatic 0/980 (0%) 0 1/984 (0.1%) 1
Lung neoplasm malignant 0/980 (0%) 0 1/984 (0.1%) 1
Metastases to lung 1/980 (0.1%) 1 0/984 (0%) 0
Ovarian adenoma 0/980 (0%) 0 1/984 (0.1%) 1
Papillary thyroid cancer 1/980 (0.1%) 1 0/984 (0%) 0
Pleural mesothelioma malignant 0/980 (0%) 0 1/984 (0.1%) 1
Prostate cancer 1/980 (0.1%) 1 1/984 (0.1%) 1
Rectal adenocarcinoma 0/980 (0%) 0 1/984 (0.1%) 1
Rectosigmoid cancer stage III 1/980 (0.1%) 1 0/984 (0%) 0
Triple negative breast cancer 1/980 (0.1%) 1 0/984 (0%) 0
Nervous system disorders
Carotid artery stenosis 1/980 (0.1%) 1 1/984 (0.1%) 1
Cerebral haemorrhage 0/980 (0%) 0 1/984 (0.1%) 1
Cerebrovascular accident 4/980 (0.4%) 4 1/984 (0.1%) 1
Dizziness 0/980 (0%) 0 1/984 (0.1%) 1
Haemorrhagic stroke 0/980 (0%) 0 1/984 (0.1%) 1
Headache 2/980 (0.2%) 2 0/984 (0%) 0
Hypoaesthesia 1/980 (0.1%) 1 0/984 (0%) 0
Hypoxic-ischaemic encephalopathy 1/980 (0.1%) 1 0/984 (0%) 0
Lacunar infarction 0/980 (0%) 0 1/984 (0.1%) 1
Lumbar radiculopathy 1/980 (0.1%) 1 0/984 (0%) 0
Spinal cord haematoma 0/980 (0%) 0 1/984 (0.1%) 1
Subarachnoid haemorrhage 0/980 (0%) 0 1/984 (0.1%) 1
Syncope 1/980 (0.1%) 1 1/984 (0.1%) 1
Transient ischaemic attack 1/980 (0.1%) 1 1/984 (0.1%) 1
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy 1/980 (0.1%) 1 0/984 (0%) 0
Psychiatric disorders
Anxiety 0/980 (0%) 0 1/984 (0.1%) 1
Completed suicide 0/980 (0%) 0 1/984 (0.1%) 1
Conversion disorder 2/980 (0.2%) 2 0/984 (0%) 0
Delusion 1/980 (0.1%) 1 0/984 (0%) 0
Delusional disorder, unspecified type 1/980 (0.1%) 1 0/984 (0%) 0
Depression 0/980 (0%) 0 1/984 (0.1%) 1
Panic attack 1/980 (0.1%) 1 0/984 (0%) 0
Psychotic disorder 1/980 (0.1%) 1 0/984 (0%) 0
Renal and urinary disorders
Acute kidney injury 6/980 (0.6%) 7 2/984 (0.2%) 2
Calculus urinary 2/980 (0.2%) 2 0/984 (0%) 0
Diabetic nephropathy 1/980 (0.1%) 1 0/984 (0%) 0
End stage renal disease 0/980 (0%) 0 1/984 (0.1%) 1
Hydronephrosis 0/980 (0%) 0 1/984 (0.1%) 1
Nephrolithiasis 2/980 (0.2%) 2 2/984 (0.2%) 3
Renal colic 0/980 (0%) 0 1/984 (0.1%) 1
Ureterolithiasis 1/980 (0.1%) 1 1/984 (0.1%) 1
Reproductive system and breast disorders
Endometriosis 1/980 (0.1%) 1 0/984 (0%) 0
Menorrhagia 0/980 (0%) 0 1/984 (0.1%) 1
Ovarian cyst 1/980 (0.1%) 1 0/984 (0%) 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure 1/980 (0.1%) 1 0/984 (0%) 0
Asthma 1/980 (0.1%) 1 0/984 (0%) 0
Chronic obstructive pulmonary disease 1/980 (0.1%) 1 1/984 (0.1%) 1
Dyspnoea 0/980 (0%) 0 1/984 (0.1%) 1
Interstitial lung disease 1/980 (0.1%) 1 0/984 (0%) 0
Pneumothorax 0/980 (0%) 0 1/984 (0.1%) 1
Pulmonary hypertension 0/980 (0%) 0 1/984 (0.1%) 1
Respiratory distress 0/980 (0%) 0 1/984 (0.1%) 1
Respiratory failure 0/980 (0%) 0 1/984 (0.1%) 1
Surgical and medical procedures
Coronary artery bypass 0/980 (0%) 0 1/984 (0.1%) 1
Gastrectomy 0/980 (0%) 0 1/984 (0.1%) 1
Gastric bypass 1/980 (0.1%) 1 0/984 (0%) 0
Metabolic surgery 1/980 (0.1%) 1 0/984 (0%) 0
Spinal laminectomy 1/980 (0.1%) 1 0/984 (0%) 0
Vascular disorders
Aortic aneurysm 1/980 (0.1%) 1 0/984 (0%) 0
Arteriosclerosis 1/980 (0.1%) 1 0/984 (0%) 0
Deep vein thrombosis 1/980 (0.1%) 1 0/984 (0%) 0
Hypertension 1/980 (0.1%) 1 2/984 (0.2%) 2
Hypotension 1/980 (0.1%) 1 0/984 (0%) 0
Hypovolaemic shock 1/980 (0.1%) 1 0/984 (0%) 0
Peripheral arterial occlusive disease 1/980 (0.1%) 1 2/984 (0.2%) 2
Peripheral artery occlusion 1/980 (0.1%) 1 0/984 (0%) 0
Peripheral artery thrombosis 1/980 (0.1%) 1 0/984 (0%) 0
Other (Not Including Serious) Adverse Events
Liraglutide 1.8 mg Oral Antidiabetic Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 65/980 (6.6%) 15/984 (1.5%)
Gastrointestinal disorders
Nausea 65/980 (6.6%) 82 15/984 (1.5%) 21

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.

Results Point of Contact

Name/Title Clinical Reporting Anchor and Disclosure (1452)
Organization Novo Nordisk A/S
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02730377
Other Study ID Numbers:
  • NN2211-4232
  • 2015-002417-29
  • U1111-1170-7035
First Posted:
Apr 6, 2016
Last Update Posted:
Jul 7, 2020
Last Verified:
Jun 1, 2020