Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial

Summary

The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable). The participant has an equal chance of being in either of the treatment groups. Neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. The study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. The participation will last about 2 years.

Timeline

Start

2018-07-13

Primary completion

2022-06-09

Completion

2023-06-09

Publications

• Buse JB, Nordahl Christensen H, Harty BJ, Cziraky MJ, Willey VJ, Skibsted S. Long-term comparative effectiveness of once-weekly semaglutide versus alternative treatments in a real-world US adult population with type 2 diabetes: a randomized pragmatic clinical trial. BMJ Open Diabetes Res Care. 2025 Oct 15;13(5):e005161. doi: 10.1136/bmjdrc-2025-005161.
• Buse JB, Nordahl Christensen H, Harty BJ, Mitchell J, Soule BP, Zacherle E, Cziraky M, Willey VJ. Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial. BMJ Open Diabetes Res Care. 2023 May;11(3):e003206. doi: 10.1136/bmjdrc-2022-003206.

Drugs

Indications