Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 245
- Locations
- 129
- Primary Endpoint
- Change in Glycated Haemoglobin (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Semaglutide 2 mg
Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
Intervention: Semaglutide (Drug)
Semaglutide placebo 2 mg
Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
Intervention: Placebo (Drug)
Semaglutide 8 mg
Participants will receive once-weekly semaglutide 8 mg s.c. injection.
Intervention: Semaglutide (Drug)
Semaglutide placebo 8 mg
Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
Intervention: Placebo (Drug)
Semaglutide 16 mg
Participants will receive once-weekly semaglutide 16 mg s.c. injection.
Intervention: Semaglutide (Drug)
Semaglutide placebo 16 mg
Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (week 0) and End of treatment (week 40)
Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.
Secondary Outcomes
- Change in Body Weight(Baseline (week 0) and End of treatment (week 40))
- Number of Treatment-emergent Adverse Events (TEAEs)(From baseline (week 0) up to end of study (week 49))
- Number of Treatment-emergent Severe Hypoglycaemic Episodes(From baseline (week 0) up to end of study (week 49))