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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05486065

U1111-1271-9209 (Other Identifier)

NN9535-4984

2022-000882-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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245 participants in 6 patient groups, including a placebo group

Semaglutide 2 mg

Experimental group

Description:

Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.

Treatment:

Drug: Semaglutide

Semaglutide placebo 2 mg

Placebo Comparator group

Description:

Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.

Treatment:

Drug: Placebo

Semaglutide 8 mg

Experimental group

Description:

Participants will receive once-weekly semaglutide 8 mg s.c. injection.

Treatment:

Drug: Semaglutide

Semaglutide placebo 8 mg

Placebo Comparator group

Description:

Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.

Treatment:

Drug: Placebo

Semaglutide 16 mg

Experimental group

Description:

Participants will receive once-weekly semaglutide 16 mg s.c. injection.

Treatment:

Drug: Semaglutide

Semaglutide placebo 16 mg

Placebo Comparator group

Description:

Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.

Treatment:

Drug: Placebo