SUSTAIN 7: Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02648204
Collaborator
(none)
1,201
209
4
16.4
5.7
0.4
Study Details
Study Description
Brief Summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes
Actual Study Start Date
:
Jan 6, 2016
Actual Primary Completion Date
:
Apr 10, 2017
Actual Study Completion Date
:
May 19, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Semaglutide 0.5 mg/Week
|
Drug: semaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
|
| Experimental: Semaglutide 1.0 mg/Week
|
Drug: semaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
|
| Active Comparator: Dulaglutide 0.75 mg/Week
|
Drug: Dulaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
|
| Active Comparator: Dulaglutide 1.5 mg/Week
|
Drug: Dulaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [Week 0, week 40]
Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Secondary Outcome Measures
- Change in Body Weight (kg) [Week 0, week 40]
Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
- Change in Fasting Plasma Glucose [Week 0, week 40]
Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
- Change in Systolic and Diastolic Blood Pressure [Week 0, week 40]
Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
- Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire [Week 0, week 40]
The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication
- HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target [After 40 weeks treatment]
Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile [Week 0, week 40]
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Change From Baseline 7-point Self-measured Plasma Glucose Increment [Week 0, week 40]
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
- Change in Fasting Blood Lipids (Total Cholesterol) [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
- Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
- Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
- Change in Fasting Blood Lipids (Triglycerides) [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
- Change in Body Mass Index (BMI) [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Change in Waist Circumference [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Change in Short Form Health Survey (SF-36v2™) [Week 0, week 40]
The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target [After 40 weeks of treatment]
Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% [After 40 weeks treatment]
Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% [After 40 weeks treatment]
Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain [After 40 weeks of treatment]
Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% [After 40 weeks of treatment]
Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% [After 40 weeks treatment]
Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% [After 40 weeks treatment]
Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
- Number of Treatment Emergent Adverse Events (TEAEs) [40 weeks + follow-up of 5 weeks]
A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes [40 weeks + follow-up of 5 weeks]
A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
- Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [40 weeks + follow-up of 5 weeks]
Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
- Change in Amylase [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
- Change in Lipase [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
- Change in Pulse Rate [Week 0, week 40]
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
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, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive)
- Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days
- History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Tuscumbia | Alabama | United States | 35674 |
| 2 | Novo Nordisk Investigational Site | Chandler | Arizona | United States | 85224 |
| 3 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85032 |
| 4 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85050 |
| 5 | Novo Nordisk Investigational Site | Anaheim | California | United States | 92801 |
| 6 | Novo Nordisk Investigational Site | Buena Park | California | United States | 90620 |
| 7 | Novo Nordisk Investigational Site | Carlsbad | California | United States | 92008 |
| 8 | Novo Nordisk Investigational Site | Concord | California | United States | 94520 |
| 9 | Novo Nordisk Investigational Site | Huntington Park | California | United States | 90255 |
| 10 | Novo Nordisk Investigational Site | Lincoln | California | United States | 95648 |
| 11 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90057 |
| 12 | Novo Nordisk Investigational Site | Montclair | California | United States | 91763 |
| 13 | Novo Nordisk Investigational Site | Poway | California | United States | 92064 |
| 14 | Novo Nordisk Investigational Site | Riverside | California | United States | 92506 |
| 15 | Novo Nordisk Investigational Site | San Diego | California | United States | 92103 |
| 16 | Novo Nordisk Investigational Site | Tustin | California | United States | 92780 |
| 17 | Novo Nordisk Investigational Site | Van Nuys | California | United States | 91405 |
| 18 | Novo Nordisk Investigational Site | Denver | Colorado | United States | 80220 |
| 19 | Novo Nordisk Investigational Site | Norwalk | Connecticut | United States | 06851 |
| 20 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33756 |
| 21 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33761 |
| 22 | Novo Nordisk Investigational Site | Coral Gables | Florida | United States | 33134 |
| 23 | Novo Nordisk Investigational Site | Edgewater | Florida | United States | 32132 |
| 24 | Novo Nordisk Investigational Site | Fort Lauderdale | Florida | United States | 33316 |
| 25 | Novo Nordisk Investigational Site | Kissimmee | Florida | United States | 34741 |
| 26 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33173 |
| 27 | Novo Nordisk Investigational Site | Orlando | Florida | United States | 32804 |
| 28 | Novo Nordisk Investigational Site | Orlando | Florida | United States | 32806 |
| 29 | Novo Nordisk Investigational Site | Pembroke Pines | Florida | United States | 33027 |
| 30 | Novo Nordisk Investigational Site | Port Orange | Florida | United States | 32127 |
| 31 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33614 |
| 32 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33634 |
| 33 | Novo Nordisk Investigational Site | Adairsville | Georgia | United States | 30103 |
| 34 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30342 |
| 35 | Novo Nordisk Investigational Site | Bainbridge | Georgia | United States | 39819 |
| 36 | Novo Nordisk Investigational Site | Conyers | Georgia | United States | 30094-5965 |
| 37 | Novo Nordisk Investigational Site | Marietta | Georgia | United States | 30060 |
| 38 | Novo Nordisk Investigational Site | Marietta | Georgia | United States | 30067 |
| 39 | Novo Nordisk Investigational Site | Suwanee | Georgia | United States | 30024 |
| 40 | Novo Nordisk Investigational Site | Meridian | Idaho | United States | 83646 |
| 41 | Novo Nordisk Investigational Site | Addison | Illinois | United States | 60101 |
| 42 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60607 |
| 43 | Novo Nordisk Investigational Site | Gillespie | Illinois | United States | 62033 |
| 44 | Novo Nordisk Investigational Site | Gurnee | Illinois | United States | 60031 |
| 45 | Novo Nordisk Investigational Site | Peoria | Illinois | United States | 61602 |
| 46 | Novo Nordisk Investigational Site | Avon | Indiana | United States | 46123 |
| 47 | Novo Nordisk Investigational Site | Evansville | Indiana | United States | 47714 |
| 48 | Novo Nordisk Investigational Site | Greenfield | Indiana | United States | 46140 |
| 49 | Novo Nordisk Investigational Site | Indianapolis | Indiana | United States | 46254 |
| 50 | Novo Nordisk Investigational Site | Muncie | Indiana | United States | 47304 |
| 51 | Novo Nordisk Investigational Site | Newton | Kansas | United States | 67114 |
| 52 | Novo Nordisk Investigational Site | Park City | Kansas | United States | 67219 |
| 53 | Novo Nordisk Investigational Site | Covington | Kentucky | United States | 41011 |
| 54 | Novo Nordisk Investigational Site | Louisville | Kentucky | United States | 40213 |
| 55 | Novo Nordisk Investigational Site | Owensboro | Kentucky | United States | 42303 |
| 56 | Novo Nordisk Investigational Site | Hyattsville | Maryland | United States | 20782 |
| 57 | Novo Nordisk Investigational Site | Oxon Hill | Maryland | United States | 20745 |
| 58 | Novo Nordisk Investigational Site | Methuen | Massachusetts | United States | 01844 |
| 59 | Novo Nordisk Investigational Site | Rochester | Michigan | United States | 48307 |
| 60 | Novo Nordisk Investigational Site | Port Gibson | Mississippi | United States | 39150 |
| 61 | Novo Nordisk Investigational Site | Missoula | Montana | United States | 59808 |
| 62 | Novo Nordisk Investigational Site | Trenton | New Jersey | United States | 08611 |
| 63 | Novo Nordisk Investigational Site | New York | New York | United States | 10016 |
| 64 | Novo Nordisk Investigational Site | Garner | North Carolina | United States | 27529 |
| 65 | Novo Nordisk Investigational Site | Whiteville | North Carolina | United States | 28472 |
| 66 | Novo Nordisk Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 67 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45242 |
| 68 | Novo Nordisk Investigational Site | Dayton | Ohio | United States | 45439 |
| 69 | Novo Nordisk Investigational Site | Mason | Ohio | United States | 45040-6815 |
| 70 | Novo Nordisk Investigational Site | Wadsworth | Ohio | United States | 44281-9236 |
| 71 | Novo Nordisk Investigational Site | Tulsa | Oklahoma | United States | 74136 |
| 72 | Novo Nordisk Investigational Site | Corvallis | Oregon | United States | 97330-3737 |
| 73 | Novo Nordisk Investigational Site | Fleetwood | Pennsylvania | United States | 19522 |
| 74 | Novo Nordisk Investigational Site | Harleysville | Pennsylvania | United States | 19438 |
| 75 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19114 |
| 76 | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | United States | 15224-2215 |
| 77 | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | United States | 15236 |
| 78 | Novo Nordisk Investigational Site | Greer | South Carolina | United States | 29651 |
| 79 | Novo Nordisk Investigational Site | Moncks Corner | South Carolina | United States | 29461 |
| 80 | Novo Nordisk Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 81 | Novo Nordisk Investigational Site | Rapid City | South Dakota | United States | 57702 |
| 82 | Novo Nordisk Investigational Site | Humboldt | Tennessee | United States | 38343 |
| 83 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76015 |
| 84 | Novo Nordisk Investigational Site | Corpus Christi | Texas | United States | 78404 |
| 85 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75230 |
| 86 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75390-9302 |
| 87 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77025 |
| 88 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77040 |
| 89 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77074 |
| 90 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77079 |
| 91 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77081 |
| 92 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77090 |
| 93 | Novo Nordisk Investigational Site | Katy | Texas | United States | 77450 |
| 94 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78231 |
| 95 | Novo Nordisk Investigational Site | Sugar Land | Texas | United States | 77479 |
| 96 | Novo Nordisk Investigational Site | Riverton | Utah | United States | 84065 |
| 97 | Novo Nordisk Investigational Site | Saint George | Utah | United States | 84790 |
| 98 | Novo Nordisk Investigational Site | Spokane | Washington | United States | 99216-1557 |
| 99 | Novo Nordisk Investigational Site | Walla Walla | Washington | United States | 99362-4445 |
| 100 | Novo Nordisk Investigational Site | Wenatchee | Washington | United States | 98801-2028 |
| 101 | Novo Nordisk Investigational Site | Blagoevgrad | Bulgaria | 2700 | |
| 102 | Novo Nordisk Investigational Site | Burgas | Bulgaria | 8000 | |
| 103 | Novo Nordisk Investigational Site | Montana | Bulgaria | 3400 | |
| 104 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1233 | |
| 105 | Novo Nordisk Investigational Site | Stara Zagora | Bulgaria | 6000 | |
| 106 | Novo Nordisk Investigational Site | Karlovac | Croatia | 47000 | |
| 107 | Novo Nordisk Investigational Site | Krapinske Toplice | Croatia | 49217 | |
| 108 | Novo Nordisk Investigational Site | Rijeka | Croatia | 51 000 | |
| 109 | Novo Nordisk Investigational Site | Varazdin | Croatia | 42 000 | |
| 110 | Novo Nordisk Investigational Site | Virovitica | Croatia | 33000 | |
| 111 | Novo Nordisk Investigational Site | Zagreb | Croatia | 10 000 | |
| 112 | Novo Nordisk Investigational Site | Jyväskylä | Finland | 40100 | |
| 113 | Novo Nordisk Investigational Site | Kerava | Finland | FI-04200 | |
| 114 | Novo Nordisk Investigational Site | Kuusamo | Finland | 93600 | |
| 115 | Novo Nordisk Investigational Site | Raisio | Finland | 21200 | |
| 116 | Novo Nordisk Investigational Site | Tampere | Finland | 33210 | |
| 117 | Novo Nordisk Investigational Site | Turku | Finland | 20520 | |
| 118 | Novo Nordisk Investigational Site | Dresden | Germany | 01219 | |
| 119 | Novo Nordisk Investigational Site | Falkensee | Germany | 14612 | |
| 120 | Novo Nordisk Investigational Site | Friedrichsthal | Germany | 66299 | |
| 121 | Novo Nordisk Investigational Site | Hamburg | Germany | 22607 | |
| 122 | Novo Nordisk Investigational Site | Münster | Germany | 48145 | |
| 123 | Novo Nordisk Investigational Site | Rehlingen-Siersburg | Germany | 66780 | |
| 124 | Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach | Germany | 66386 | |
| 125 | Novo Nordisk Investigational Site | Athens | Greece | 115 25 | |
| 126 | Novo Nordisk Investigational Site | Athens | Greece | GR-17562 | |
| 127 | Novo Nordisk Investigational Site | Chalkida, Evia | Greece | GR-34100 | |
| 128 | Novo Nordisk Investigational Site | Ioannina | Greece | 45500 | |
| 129 | Novo Nordisk Investigational Site | Piraeus | Greece | GR-18536 | |
| 130 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54636 | |
| 131 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-57001 | |
| 132 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-57010 | |
| 133 | Novo Nordisk Investigational Site | Shatin, New Territories | Hong Kong | ||
| 134 | Novo Nordisk Investigational Site | Guntur | Andhra Pradesh | India | 522001 |
| 135 | Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | India | 500004 |
| 136 | Novo Nordisk Investigational Site | Visakhapatnam | Andhra Pradesh | India | 530002 |
| 137 | Novo Nordisk Investigational Site | Guwahati | Assam | India | 781008 |
| 138 | Novo Nordisk Investigational Site | Ahmedabad | Gujarat | India | 380007 |
| 139 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560002 |
| 140 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560054 |
| 141 | Novo Nordisk Investigational Site | Kochi | Kerala | India | 682041 |
| 142 | Novo Nordisk Investigational Site | Kozhikode | Kerala | India | 673017 |
| 143 | Novo Nordisk Investigational Site | Indore | Madhya Pradesh | India | 452008 |
| 144 | Novo Nordisk Investigational Site | Goa | Maharashtra | India | 403 202 |
| 145 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400008 |
| 146 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400022 |
| 147 | Novo Nordisk Investigational Site | Pune | Maharashtra | India | 411004 |
| 148 | Novo Nordisk Investigational Site | Pune | Maharashtra | India | 411040 |
| 149 | Novo Nordisk Investigational Site | Delhi | New Delhi | India | 110002 |
| 150 | Novo Nordisk Investigational Site | New Dehli | New Delhi | India | 110029 |
| 151 | Novo Nordisk Investigational Site | Bhubaneswar | Orissa | India | 751005 |
| 152 | Novo Nordisk Investigational Site | Mohali | Punjab | India | 160062 |
| 153 | Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India | 600086 |
| 154 | Novo Nordisk Investigational Site | Vellore | Tamil Nadu | India | 632004 |
| 155 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700017 |
| 156 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700020 |
| 157 | Novo Nordisk Investigational Site | Hyderabad | India | 500 012 | |
| 158 | Novo Nordisk Investigational Site | Ludhiana | India | 141001 | |
| 159 | Novo Nordisk Investigational Site | New Delhi | India | 110001 | |
| 160 | Novo Nordisk Investigational Site | Dublin | Ireland | DUBLIN 15 | |
| 161 | Novo Nordisk Investigational Site | Dublin | Ireland | DUBLIN 4 | |
| 162 | Novo Nordisk Investigational Site | Dublin | Ireland | DUBLIN 7 | |
| 163 | Novo Nordisk Investigational Site | Galway | Ireland | H91 YR71 | |
| 164 | Novo Nordisk Investigational Site | Gorey | Ireland | ||
| 165 | Novo Nordisk Investigational Site | Riga | Latvia | LV-1002 | |
| 166 | Novo Nordisk Investigational Site | Riga | Latvia | LV-1024 | |
| 167 | Novo Nordisk Investigational Site | Riga | Latvia | LV-1038 | |
| 168 | Novo Nordisk Investigational Site | Kaunas | Lithuania | 48259 | |
| 169 | Novo Nordisk Investigational Site | Kaunas | Lithuania | 50009 | |
| 170 | Novo Nordisk Investigational Site | Panevezys | Lithuania | 37355 | |
| 171 | Novo Nordisk Investigational Site | Vilnius | Lithuania | 04318 | |
| 172 | Novo Nordisk Investigational Site | Vilnius | Lithuania | 08661 | |
| 173 | Novo Nordisk Investigational Site | Almada | Portugal | 2805-267 | |
| 174 | Novo Nordisk Investigational Site | Aveiro | Portugal | 3814-501 | |
| 175 | Novo Nordisk Investigational Site | Lisboa | Portugal | 1250-230 | |
| 176 | Novo Nordisk Investigational Site | Tomar | Portugal | 2304-909 | |
| 177 | Novo Nordisk Investigational Site | Viana do Castelo | Portugal | 4901-858 | |
| 178 | Novo Nordisk Investigational Site | Vila Nova de Gaia | Portugal | 4434-502 | |
| 179 | Novo Nordisk Investigational Site | Ponce | Puerto Rico | 00716 | |
| 180 | Novo Nordisk Investigational Site | Oradea | Bihor | Romania | 410469 |
| 181 | Novo Nordisk Investigational Site | Tirgu Mures | Mures | Romania | 540142 |
| 182 | Novo Nordisk Investigational Site | Brasov | Romania | 500101 | |
| 183 | Novo Nordisk Investigational Site | Bucharest | Romania | 010507 | |
| 184 | Novo Nordisk Investigational Site | Bucharest | Romania | 13682 | |
| 185 | Novo Nordisk Investigational Site | Buzau | Romania | 120203 | |
| 186 | Novo Nordisk Investigational Site | Galati | Romania | 800578 | |
| 187 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 81108 | |
| 188 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 851 01 | |
| 189 | Novo Nordisk Investigational Site | Levice | Slovakia | 93401 | |
| 190 | Novo Nordisk Investigational Site | Piestany | Slovakia | 92101 | |
| 191 | Novo Nordisk Investigational Site | Poprad | Slovakia | 05801 | |
| 192 | Novo Nordisk Investigational Site | Prievidza | Slovakia | 97101 | |
| 193 | Novo Nordisk Investigational Site | Alicante | Spain | 03010 | |
| 194 | Novo Nordisk Investigational Site | La Roca del Vallés | Spain | 08430 | |
| 195 | Novo Nordisk Investigational Site | Madrid | Spain | 28009 | |
| 196 | Novo Nordisk Investigational Site | Málaga | Spain | 29006 | |
| 197 | Novo Nordisk Investigational Site | Palma de Mallorca | Spain | 07010 | |
| 198 | Novo Nordisk Investigational Site | Palma de Mallorca | Spain | 07014 | |
| 199 | Novo Nordisk Investigational Site | Segovia | Spain | 40002 | |
| 200 | Novo Nordisk Investigational Site | Sevilla | Spain | 41010 | |
| 201 | Novo Nordisk Investigational Site | Vic (Barcelona) | Spain | 08500 | |
| 202 | Novo Nordisk Investigational Site | Bradford-on-Avon | United Kingdom | BA15 1DQ | |
| 203 | Novo Nordisk Investigational Site | Northwood | United Kingdom | HA6 2RN | |
| 204 | Novo Nordisk Investigational Site | Romford | United Kingdom | RM1 3PJ | |
| 205 | Novo Nordisk Investigational Site | Soham | United Kingdom | CB7 5JD | |
| 206 | Novo Nordisk Investigational Site | Southampton | United Kingdom | SO16 6YD | |
| 207 | Novo Nordisk Investigational Site | Southampton | United Kingdom | SO30 3JB | |
| 208 | Novo Nordisk Investigational Site | Stevenage | United Kingdom | SG1 4AB | |
| 209 | Novo Nordisk Investigational Site | Watford | United Kingdom | WD25 7NL |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Johansen P, Håkan-Bloch J, Liu AR, Bech PG, Persson S, Leiter LA. Cost Effectiveness of Once-Weekly Semaglutide Versus Once-Weekly Dulaglutide in the Treatment of Type 2 Diabetes in Canada. Pharmacoecon Open. 2019 Dec;3(4):537-550. doi: 10.1007/s41669-019-0131-6.
- Malkin SJP, Russel-Szymczyk M, Psota M, Hlavinkova L, Hunt B. The Management of Type 2 Diabetes with Once-Weekly Semaglutide Versus Dulaglutide: A Long-Term Cost-Effectiveness Analysis in Slovakia. Adv Ther. 2019 Aug;36(8):2034-2051. doi: 10.1007/s12325-019-00965-y. Epub 2019 Jun 5.
- Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02648204
Other Study ID Numbers:
- NN9535-4216
- 2014-005375-91
- U1111-1164-8495
First Posted:
Jan 6, 2016
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Study Results
Participant Flow
| Recruitment Details | A total of 210 sites were approved for recruiting subjects, of which 196 sites randomized the subjects: Bulgaria: 6; Croatia: 6; Finland: 6; Germany: 6; Greece: 8; Hong Kong: 1; India: 22; Ireland: 5; Latvia: 3; Lithuania: 5; Portugal: 4; Romania: 7; Slovakia: 6; Spain: 8; United Kingdom: 8; United States: 95. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (week 1 to 4) followed by 0.5 mg for another 4 weeks (week 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (week 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Period Title: Overall Study | ||||
| STARTED | 301 | 300 | 300 | 300 |
| Exposed | 301 | 300 | 299 | 299 |
| COMPLETED | 279 | 279 | 287 | 284 |
| NOT COMPLETED | 22 | 21 | 13 | 16 |
Baseline Characteristics
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Total of all reporting groups |
| Overall Participants | 301 | 300 | 299 | 299 | 1199 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
56
(10.9)
|
55
(10.6)
|
55
(10.4)
|
56
(10.6)
|
56
(10.6)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
169
56.1%
|
162
54%
|
160
53.5%
|
171
57.2%
|
662
55.2%
|
| Male |
132
43.9%
|
138
46%
|
139
46.5%
|
128
42.8%
|
537
44.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
29
9.6%
|
35
11.7%
|
31
10.4%
|
43
14.4%
|
138
11.5%
|
| Not Hispanic or Latino |
272
90.4%
|
265
88.3%
|
268
89.6%
|
256
85.6%
|
1061
88.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
50
16.6%
|
38
12.7%
|
48
16.1%
|
55
18.4%
|
191
15.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
17
5.6%
|
18
6%
|
17
5.7%
|
18
6%
|
70
5.8%
|
| White |
233
77.4%
|
243
81%
|
232
77.6%
|
220
73.6%
|
928
77.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
0.3%
|
1
0.3%
|
2
0.7%
|
6
2%
|
10
0.8%
|
| Glycosylated haemoglobin (Hb1Ac) (percentage of HbA1c) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [percentage of HbA1c] |
8.3
(0.96)
|
8.2
(0.92)
|
8.2
(0.91)
|
8.2
(0.89)
|
8.2
(0.92)
|
| Body weight (kg) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kg] |
96.4
(24.38)
|
95.5
(20.90)
|
95.6
(23.01)
|
93.4
(21.79)
|
95.2
(22.56)
|
| Fasting plasma glucose (mmol/L) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mmol/L] |
9.8
(2.54)
|
9.8
(2.58)
|
9.7
(2.65)
|
9.6
(2.29)
|
9.7
(2.52)
|
Outcome Measures
| Title | Change in HbA1c |
|---|---|
| Description | Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Least Squares Mean (Standard Error) [percentage of HbA1c] |
-1.51
(0.06)
|
-1.78
(0.06)
|
-1.11
(0.05)
|
-1.37
(0.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 0.5 mg, Dulaglutide 0.75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Non-Inferiority margin: 0.4 | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.08 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 0.5 mg, Dulaglutide 0.75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.08 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 1.0 mg, Dulaglutide 1.5 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Non-Inferiority margin: 0.04 | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.08 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 1.0 mg, Dulaglutide 1.5 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.08 |
|
| Estimation Comments | ||
| Title | Change in Body Weight (kg) |
|---|---|
| Description | Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 298 |
| Least Squares Mean (Standard Error) [kg] |
-4.56
(0.28)
|
-6.53
(0.28)
|
-2.30
(0.27)
|
-2.98
(0.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 0.5 mg, Dulaglutide 0.75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -2.26 | |
| Confidence Interval |
(2-Sided) 95% -3.02 to -1.51 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Semaglutide 1.0 mg, Dulaglutide 1.5 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -3.55 | |
| Confidence Interval |
(2-Sided) 95% -4.32 to -2.78 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
| Estimation Comments | ||
| Title | Change in Fasting Plasma Glucose |
|---|---|
| Description | Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 298 | 299 | 297 | 297 |
| Least Squares Mean (Standard Error) [mmol/L] |
-2.18
(0.12)
|
-2.83
(0.12)
|
-1.87
(0.12)
|
-2.25
(0.12)
|
| Title | Change in Systolic and Diastolic Blood Pressure |
|---|---|
| Description | Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Diastolic BP |
-0.57
(0.48)
|
-2.05
(0.49)
|
-0.35
(0.47)
|
-0.03
(0.47)
|
| Systolic BP |
-2.44
(0.76)
|
-4.88
(0.77)
|
-2.16
(0.75)
|
-2.86
(0.75)
|
| Title | Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire |
|---|---|
| Description | The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for diabetes treatment satisfaction questionnaire |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 299 | 299 | 298 |
| Least Squares Mean (Standard Error) [units on a scale] |
4.60
(0.28)
|
4.55
(0.29)
|
4.52
(0.28)
|
4.65
(0.28)
|
| Title | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target |
|---|---|
| Description | Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | After 40 weeks treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Results are based on the FAS. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Yes |
49.2
|
66.7
|
34.1
|
47.2
|
| No |
50.8
|
33.3
|
65.9
|
52.8
|
| Title | Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile |
|---|---|
| Description | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 295 | 295 | 296 | 296 |
| Least Squares Mean (Standard Error) [mmol/L] |
-2.43
(0.10)
|
-2.95
(0.10)
|
-1.99
(0.10)
|
-2.32
(0.10)
|
| Title | Change From Baseline 7-point Self-measured Plasma Glucose Increment |
|---|---|
| Description | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose increment. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 295 | 292 | 296 | 296 |
| Least Squares Mean (Standard Error) [mmol/L] |
-0.77
(0.08)
|
-0.93
(0.09)
|
-0.44
(0.08)
|
-0.63
(0.08)
|
| Title | Change in Fasting Blood Lipids (Total Cholesterol) |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for total cholesterol |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 295 | 296 | 290 | 294 |
| Geometric Least Squares Mean (Standard Error) [ratio to baseline] |
0.96
(0.01)
|
0.97
(0.01)
|
0.97
(0.01)
|
0.99
(0.01)
|
| Title | Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for LDL cholesterol. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 293 | 295 | 290 | 294 |
| Geometric Least Squares Mean (Standard Error) [ratio to baseline] |
0.97
(0.02)
|
1.00
(0.02)
|
0.97
(0.02)
|
1.01
(0.02)
|
| Title | Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for HDL cholesterol. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 293 | 296 | 290 | 294 |
| Geometric Least Squares Mean (Standard Error) [ratio to baseline] |
0.99
(0.01)
|
1.01
(0.01)
|
1.00
(0.01)
|
1.02
(0.01)
|
| Title | Change in Fasting Blood Lipids (Triglycerides) |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for triglycerides. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 293 | 296 | 290 | 294 |
| Geometric Least Squares Mean (Standard Error) [ratio to baseline] |
0.91
(0.02)
|
0.86
(0.02)
|
0.91
(0.02)
|
0.90
(0.02)
|
| Title | Change in Body Mass Index (BMI) |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for BMI. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 298 |
| Least Squares Mean (Standard Error) [kg/m^2] |
-1.63
(0.10)
|
-2.33
(0.10)
|
-0.82
(0.10)
|
-1.08
(0.10)
|
| Title | Change in Waist Circumference |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for waist circumference. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 299 | 300 | 298 | 297 |
| Least Squares Mean (Standard Error) [cm] |
-4.27
(0.34)
|
-5.20
(0.34)
|
-2.36
(0.33)
|
-2.93
(0.33)
|
| Title | Change in Short Form Health Survey (SF-36v2™) |
|---|---|
| Description | The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number analysed=number of participants with available data for SF-36. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Physical component summary |
1.21
(0.40)
|
2.04
(0.40)
|
1.93
(0.39)
|
1.29
(0.39)
|
| Mental component summary |
1.45
(0.49)
|
1.23
(0.49)
|
0.95
(0.48)
|
1.08
(0.48)
|
| Physical functioning |
1.25
(0.44)
|
2.00
(0.44)
|
2.17
(0.43)
|
1.05
(0.43)
|
| Role-physical |
0.98
(0.48)
|
2.03
(0.48)
|
1.39
(0.47)
|
0.82
(0.47)
|
| Bodily pain |
0.96
(0.52)
|
1.54
(0.52)
|
1.69
(0.51)
|
0.77
(0.51)
|
| General health |
2.65
(0.43)
|
2.52
(0.43)
|
1.86
(0.42)
|
2.73
(0.42)
|
| Vitality |
1.23
(0.50)
|
1.97
(0.50)
|
2.14
(0.49)
|
1.83
(0.50)
|
| Social functioning |
1.18
(0.49)
|
0.83
(0.49)
|
0.78
(0.48)
|
0.63
(0.48)
|
| Role-emotional |
1.11
(0.57)
|
1.57
(0.58)
|
1.04
(0.56)
|
1.08
(0.57)
|
| Mental health |
1.89
(0.49)
|
1.65
(0.49)
|
1.43
(0.48)
|
0.96
(0.48)
|
| Title | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target |
|---|---|
| Description | Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | After 40 weeks of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Yes |
68.4
|
78.7
|
52.2
|
66.6
|
| No |
31.6
|
21.3
|
47.8
|
33.4
|
| Title | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% |
|---|---|
| Description | Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | After 40 weeks treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 298 |
| Yes |
43.9
|
63.0
|
22.7
|
30.2
|
| No |
56.1
|
37.0
|
77.3
|
69.8
|
| Title | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% |
|---|---|
| Description | Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | After 40 weeks treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 298 |
| Yes |
14.3
|
26.7
|
3.3
|
7.7
|
| No |
85.7
|
73.3
|
96.7
|
92.3
|
| Title | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain |
|---|---|
| Description | Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit |
| Time Frame | After 40 weeks of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for this endpoint. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 298 |
| Yes |
64.5
|
74.0
|
44.1
|
58.4
|
| No |
35.5
|
26.0
|
55.9
|
41.6
|
| Title | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% |
|---|---|
| Description | Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | After 40 weeks of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Yes |
77.4
|
83.3
|
53.8
|
67.6
|
| No |
22.6
|
16.7
|
46.2
|
32.4
|
| Title | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% |
|---|---|
| Description | Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | After 40 weeks treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 298 |
| Yes |
64.5
|
76.7
|
36.5
|
44.6
|
| No |
35.5
|
23.3
|
63.5
|
55.4
|
| Title | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% |
|---|---|
| Description | Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | After 40 weeks treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on FAS. Number of participants analysed=number of participants with available data for HbA1c and body weight. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 298 |
| Yes |
53.2
|
68.3
|
25.1
|
34.9
|
| No |
46.8
|
31.7
|
74.9
|
65.1
|
| Title | Number of Treatment Emergent Adverse Events (TEAEs) |
|---|---|
| Description | A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). |
| Time Frame | 40 weeks + follow-up of 5 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Number [events] |
966
|
1015
|
802
|
957
|
| Title | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes |
|---|---|
| Description | A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Time Frame | 40 weeks + follow-up of 5 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Number [hypoglycaemic episodes] |
3
|
7
|
3
|
5
|
| Title | Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
|---|---|
| Description | Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Time Frame | 40 weeks + follow-up of 5 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Number [percentage of subjects] |
0.7
|
1.7
|
1.0
|
1.7
|
| Title | Change in Amylase |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for amylase. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 295 | 296 | 292 | 294 |
| Geometric Least Squares Mean (Standard Error) [ratio to baseline] |
1.17
(0.02)
|
1.22
(0.02)
|
1.16
(0.02)
|
1.20
(0.02)
|
| Title | Change in Lipase |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for lipase. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 295 | 296 | 291 | 293 |
| Geometric Least Squares Mean (Standard Error) [ratio to baseline] |
1.22
(0.04)
|
1.32
(0.04)
|
1.23
(0.04)
|
1.29
(0.04)
|
| Title | Change in Pulse Rate |
|---|---|
| Description | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Time Frame | Week 0, week 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on safety analysis set. |
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Measure Participants | 301 | 300 | 299 | 299 |
| Least Squares Mean (Standard Error) [beats/min] |
2.09
(0.51)
|
3.96
(0.51)
|
1.56
(0.49)
|
2.42
(0.50)
|
Adverse Events
| Time Frame | Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days) | |||||||
| Arm/Group Title | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg | ||||
| Arm/Group Description | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | ||||
All Cause Mortality |
||||||||
| Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/301 (0%) | 1/300 (0.3%) | 2/299 (0.7%) | 2/299 (0.7%) | ||||
Serious Adverse Events |
||||||||
| Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/301 (5.6%) | 23/300 (7.7%) | 24/299 (8%) | 22/299 (7.4%) | ||||
| Cardiac disorders | ||||||||
| Angina pectoris | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Angina unstable | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 2/299 (0.7%) | 2 |
| Aortic valve stenosis | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Atrial fibrillation | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 2/299 (0.7%) | 2 |
| Atrial flutter | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Atrioventricular block complete | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Cardio-respiratory arrest | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 1/299 (0.3%) | 1 |
| Congestive cardiomyopathy | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Coronary artery stenosis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 1/299 (0.3%) | 1 |
| Myocardial infarction | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Ventricular extrasystoles | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Acute vestibular syndrome | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Colitis | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Crohn's disease | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Gastroduodenitis | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Haemorrhoids | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Impaired gastric emptying | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Inguinal hernia | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Nausea | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Pancreatitis acute | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Pancreatolithiasis | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Rectal prolapse | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Vomiting | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| General disorders | ||||||||
| Drowning | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Multiple organ dysfunction syndrome | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Non-cardiac chest pain | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Cholecystitis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Cholecystitis acute | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 2/299 (0.7%) | 2 |
| Cholelithiasis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Gallbladder pain | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Hepatic cirrhosis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Immune system disorders | ||||||||
| Hypersensitivity | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Sarcoidosis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Infections and infestations | ||||||||
| Appendicitis | 2/301 (0.7%) | 2 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Bronchitis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Cellulitis | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Gastroenteritis viral | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| HIV infection | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Kidney infection | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Perirectal abscess | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Pneumonia | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 1/299 (0.3%) | 1 |
| Postoperative wound infection | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Pyelonephritis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Sepsis | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Upper respiratory tract infection | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Urinary tract infection | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Face injury | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Fall | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Femur fracture | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Meniscus injury | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Post procedural myocardial infarction | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Road traffic accident | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 1/299 (0.3%) | 1 |
| Tibia fracture | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Investigations | ||||||||
| Lipase increased | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Diabetic complication | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Hypercalcaemia | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Hypoglycaemia | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 2/299 (0.7%) | 2 | 0/299 (0%) | 0 |
| Intervertebral disc degeneration | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Intervertebral disc protrusion | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Musculoskeletal chest pain | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Spinal column stenosis | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Bladder cancer | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Lipoma | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 2 | 0/299 (0%) | 0 |
| Malignant neoplasm of ampulla of Vater | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Metastatic squamous cell carcinoma | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Pancreatic carcinoma stage IV | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Rectal adenocarcinoma | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Rectal cancer | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Nervous system disorders | ||||||||
| Carpal tunnel syndrome | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 2/299 (0.7%) | 2 | 0/299 (0%) | 0 |
| Cerebral infarction | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Diabetic neuropathy | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Hypoglycaemic unconsciousness | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Paraesthesia | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Anxiety | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Depression | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Suicide attempt | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 1/301 (0.3%) | 1 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Renal colic | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Ureterolithiasis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Cystocele | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Uterine prolapse | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Acute respiratory failure | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Chronic obstructive pulmonary disease | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Epistaxis | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Pulmonary embolism | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| Cardioversion | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Gastrectomy | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Hip arthroplasty | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Hospitalisation | 1/301 (0.3%) | 1 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
| Hysterectomy | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 1/299 (0.3%) | 1 | 0/299 (0%) | 0 |
| Orchidectomy | 0/301 (0%) | 0 | 0/300 (0%) | 0 | 0/299 (0%) | 0 | 1/299 (0.3%) | 1 |
| Vascular disorders | ||||||||
| Hypertensive crisis | 0/301 (0%) | 0 | 1/300 (0.3%) | 1 | 0/299 (0%) | 0 | 0/299 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 132/301 (43.9%) | 134/300 (44.7%) | 106/299 (35.5%) | 139/299 (46.5%) | ||||
| Gastrointestinal disorders | ||||||||
| Constipation | 16/301 (5.3%) | 18 | 14/300 (4.7%) | 14 | 10/299 (3.3%) | 10 | 15/299 (5%) | 18 |
| Diarrhoea | 43/301 (14.3%) | 79 | 41/300 (13.7%) | 96 | 23/299 (7.7%) | 42 | 53/299 (17.7%) | 75 |
| Nausea | 67/301 (22.3%) | 144 | 63/300 (21%) | 192 | 39/299 (13%) | 66 | 60/299 (20.1%) | 108 |
| Vomiting | 30/301 (10%) | 50 | 31/300 (10.3%) | 48 | 12/299 (4%) | 16 | 29/299 (9.7%) | 40 |
| Infections and infestations | ||||||||
| Nasopharyngitis | 15/301 (5%) | 16 | 14/300 (4.7%) | 16 | 17/299 (5.7%) | 20 | 20/299 (6.7%) | 24 |
| Upper respiratory tract infection | 13/301 (4.3%) | 18 | 10/300 (3.3%) | 11 | 21/299 (7%) | 26 | 16/299 (5.4%) | 21 |
| Investigations | ||||||||
| Lipase increased | 19/301 (6.3%) | 23 | 17/300 (5.7%) | 17 | 16/299 (5.4%) | 17 | 17/299 (5.7%) | 20 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 25/301 (8.3%) | 26 | 27/300 (9%) | 27 | 9/299 (3%) | 12 | 31/299 (10.4%) | 36 |
| Nervous system disorders | ||||||||
| Headache | 25/301 (8.3%) | 35 | 22/300 (7.3%) | 30 | 12/299 (4%) | 20 | 19/299 (6.4%) | 30 |
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 |
| clinicaltrials@novonordisk.com |
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02648204
Other Study ID Numbers:
- NN9535-4216
- 2014-005375-91
- U1111-1164-8495
First Posted:
Jan 6, 2016
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019