A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
Study Details
Study Description
Brief Summary
This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide [2 milligrams (mg), 8 mg, or 16 mg] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Semaglutide 2 mg Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection. |
Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
|
| Placebo Comparator: Semaglutide placebo 2 mg Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection. |
Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
|
| Experimental: Semaglutide 8 mg Participants will receive once-weekly semaglutide 8 mg s.c. injection. |
Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
|
| Placebo Comparator: Semaglutide placebo 8 mg Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection. |
Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
|
| Experimental: Semaglutide 16 mg Participants will receive once-weekly semaglutide 16 mg s.c. injection. |
Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
|
| Placebo Comparator: Semaglutide placebo 16 mg Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection. |
Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
|
Outcome Measures
Primary Outcome Measures
- Change in Glycosylated Haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 40)]
Measured as percentage
Secondary Outcome Measures
- Change in Body Weight [From baseline (week 0) to end of treatment (week 40)]
Measured as kilogram
- Number of Treatment-emergent Adverse Events (TEAEs) [From baseline (week 0) to end of study (week 49)]
Measured as count of events
- Number of Treatment-emergent Severe Hypoglycaemic Episodes [From baseline (week 0) to end of study (week 49)]
Measured as number of episodes
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female.
-
Aged 18-64 years (both inclusive) at the time of signing informed consent.
-
Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
-
Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] (both inclusive).
-
Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2).
-
Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.
Exclusion Criteria:
-
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
-
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
-
Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 30 milliliters per minute (mL/min)/1.73 meter square (m^2) at screening.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9535-4984
- U1111-1271-9209
- 2022-000882-41