A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
• Placebo — DRUG
  Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.

Study Details

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.

Key Dates

Start date

Aug 8, 2022

Status verified

Nov 2025

Primary completion

Oct 12, 2023

Completion

Dec 13, 2023

Study Design

Enrollment

245 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 2 mg
  Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
• Placebo Comparator: Semaglutide placebo 2 mg
  Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
• Experimental: Semaglutide 8 mg
  Participants will receive once-weekly semaglutide 8 mg s.c. injection.
• Placebo Comparator: Semaglutide placebo 8 mg
  Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
• Experimental: Semaglutide 16 mg
  Participants will receive once-weekly semaglutide 16 mg s.c. injection.
• Placebo Comparator: Semaglutide placebo 16 mg
  Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.

Primary Outcome Measure

Change in Glycated Haemoglobin (HbA1c) [ Time Frame: Baseline (week 0) and End of treatment (week 40) ]

Locations (101)

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