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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: No
View:

• 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.

Locations
United States
Alabama
Novo Nordisk Investigational Site
Recruiting
Birmingham
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: August 8, 2022
Estimated Completion Date: December 22, 2023
Participants
Target number of participants: 240
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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