Efficacy and safety of semaglutide injection in Indian patients with type 2 diabetes mellitus inadequately controlled on metformin: a phase 3, randomized, active-controlled trial (SIZE-DM study)
Generic semaglutide works as well as the brand version for Indian diabetes patients, potentially making this effective weight-loss therapy far more affordable worldwide.
This Phase 3 RCT in 320 Indian T2DM patients on metformin showed that a generic formulation of semaglutide achieved equivalent glycemic control (-2.20% HbA1c) and weight reduction compared to the Novo Nordisk innovator product with a comparable safety profile. Generic semaglutide approval for resource-limited settings could substantially improve access to effective GLP-1 therapy in the world's most populous diabetes epidemic.
What the study was
- Study design
- Phase 3 multicenter randomized active-controlled non-inferiority trial
- Population
- Indian adults with T2DM inadequately controlled on metformin; n=320
- Sample size
- 320
- Category
- Treatment Innovation
- Maturity
- Validated
- Journal
- Cardiovascular Diabetology. Endocrinology Reports
Why it surfaced
First Phase 3 non-inferiority trial of generic semaglutide in Indian T2DM population; strong design with 320 participants; implications for access in LMIC where diabetes burden is highest.
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