A Phase 3 interventional study of Semaglutide and Placebo (semaglutide) in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 129 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-13.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.
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Exclusion Criteria:
All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.
Drug: Semaglutide
All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.
Drug: Semaglutide · Drug: Placebo (semaglutide)
Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
Semaglutide placebo injected once-weekly from week 13 to week 40.
Change in HbA1c
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Time frame: Week 0, week 40
Change in Body Weight
Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Time frame: Week 0, week 40
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Time frame: Week 0, week 40
Change in Body Mass Index (BMI)
Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Time frame: Week 0, week 40
Change in Waist Circumference
Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Time frame: Week 0, week 40
Participants Who Achieved HbA1c < 7.0%
Percentage of participants who achieved HbA1c \< 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Time frame: Week 40
Participants Who Achieved HbA1c ≤ 6.5%
Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Time frame: Week 40
Participants Who Achieved Weight Loss ≥5%
Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Time frame: Week 40
Participants Who Achieved Weight Loss ≥10%
Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Time frame: Week 40
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.
Time frame: Week 0 to week 47
Change in Pulse Rate
Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.
Time frame: Week 0, week 40
The trial was conducted at 125 sites in Bulgaria (9), Canada (8), Czech Republic (4), Greece (6), Hungary (12), Japan (2), Poland (10), Slovakia (11), Ukraine (5) and the United States (58). In addition to these sites, 4 sites in the US screened but did not randomize participants, and 3 sites were approved by the IRB/IEC but did not screen or assign any participants to treatment.
| Milestone | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Started | 481 | 480 |
| Exposed | 480 | 479 |
| Safety analysis set (sas) | 480 | 479 |
| Full analysis set (fas) | 481 | 480 |
| Completed | 471 | 462 |
| Not completed | 10 | 18 |
| Withdrew: Lost to follow-up | 3 | 10 |
| Withdrew: Withdrawal by subject | 6 | 6 |
| Withdrew: Death | 1 | 2 |
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
| Percentage change | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| On-treatment without rescue medication | -2.0 ± 1.0 | -2.2 ± 1.0 |
| In-trial | -1.9 ± 1.0 | -2.2 ± 1.1 |
Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
| Kilogram (kg) | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| On-treatment without rescue medication | -6.0 ± 5.8 | -7.0 ± 5.8 |
| In-trial | -5.7 ± 5.9 | -6.7 ± 5.9 |
Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
| Millimoles per liter (mmol/L) | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | -3.2 ± 2.8 | -3.4 ± 3.1 |
Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
| Kilogram per squaremeter (Kg/m^2) | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Change in Body Mass Index (BMI) | -2.1 ± 2.1 | -2.5 ± 2.1 |
Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
| Centimeter (cm) | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Change in Waist Circumference | -5.2 ± 6.1 | -5.9 ± 6.2 |
Percentage of participants who achieved HbA1c \< 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
| Percentage of participants | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Participants Who Achieved HbA1c < 7.0% | 57.5 | 67.6 |
Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
| Percentage of participants | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Participants Who Achieved HbA1c ≤ 6.5% | 38.5 | 51.7 |
Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
| Percentage of participants | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Participants Who Achieved Weight Loss ≥5% | 51.3 | 59.2 |
Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
| Percentage of participants | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Participants Who Achieved Weight Loss ≥10% | 22.6 | 28.4 |
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.
| Episodes | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 28 | 21 |
Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.
| Beats per minute | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Change in Pulse Rate | 2.8 ± 10.0 | 3.3 ± 9.5 |
Collected over Weeks 0-47. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Semaglutide 1.0 mg | 1/480 (0.2%) | 25/480 (5.2%) | 126/480 (26.3%) |
| Semaglutide 2.0 mg | 2/479 (0.4%) | 21/479 (4.4%) | 132/479 (27.6%) |
| Event | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| Coronary artery stenosisCardiac disorders | 3/480 | 0/479 |
| Acute kidney injuryRenal and urinary disorders | 2/480 | 2/479 |
| Acute myocardial infarctionCardiac disorders | 2/480 | 1/479 |
| DehydrationMetabolism and nutrition disorders | 2/480 | 0/479 |
| HypokalaemiaMetabolism and nutrition disorders | 2/480 | 0/479 |
| Adenocarcinoma pancreasNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/480 | 1/479 |
| AnaemiaBlood and lymphatic system disorders | 0/480 | 1/479 |
| Angina pectorisCardiac disorders | 0/480 | 1/479 |
| Aortic dissectionVascular disorders | 0/480 | 1/479 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/480 | 1/479 |
| Event | Semaglutide 1.0 mg | Semaglutide 2.0 mg |
|---|---|---|
| NauseaGastrointestinal disorders | 70/480 | 69/479 |
| DiarrhoeaGastrointestinal disorders | 42/480 | 45/479 |
| VomitingGastrointestinal disorders | 32/480 | 37/479 |
| Decreased appetiteMetabolism and nutrition disorders | 18/480 | 29/479 |
| DyspepsiaGastrointestinal disorders | 25/480 | 16/479 |
The full analysis set (FAS) included all randomized participants.
| Age, Continuous(Years) | Semaglutide 1.0 mg | Semaglutide 2.0 mg | Total |
|---|---|---|---|
| Mean | 58.2 ± 9.9 | 57.9 ± 10.0 | 58.0 ± 10.0 |
| Sex: Female, Male(Participants) | Semaglutide 1.0 mg | Semaglutide 2.0 mg | Total |
|---|---|---|---|
| Female | 197 | 201 | 398 |
| Male | 284 | 279 | 563 |
| Ethnicity (NIH/OMB)(Participants) | Semaglutide 1.0 mg | Semaglutide 2.0 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 59 | 52 | 111 |
| Not Hispanic or Latino | 422 | 428 | 850 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Semaglutide 1.0 mg | Semaglutide 2.0 mg | Total |
|---|---|---|---|
| American Indian or Alaska native | 1 | 0 | 1 |
| Asian | 36 | 33 | 69 |
| Black or African American | 17 | 26 | 43 |
| Native Hawaiian or Other Pacific | 0 | 0 | 0 |
| White | 427 | 420 | 847 |
| Other | 0 | 1 | 1 |
Showing the first 100 of 129 sites across 11 countries.
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