Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III, Active-Controlled Study
A lower-cost GLP-1 therapy works as well as the brand-name version in Indian diabetic patients, expanding affordable access.
This Phase 3 Indian RCT (n=314) demonstrated non-inferiority of a synthetic semaglutide formulation vs branded Ozempic for glycemic control (HbA1c reduction -2.04% vs -1.95%) with equivalent body weight reduction and safety over 24 weeks. The findings support access expansion for GLP-1 therapy in the underserved Indian T2DM population through a lower-cost alternative.
What the study was
- Study design
- Phase 3 RCT (non-inferiority, active-controlled, open-label)
- Population
- Indian adults aged 18-65 with T2DM (HbA1c 7.0-10.5%) on stable metformin; 35 centers across India
- Sample size
- 314
- Category
- Treatment Innovation
- Maturity
- Validated
- Journal
- Diabetes Obes Metab
Why it surfaced
Phase 3 RCT supporting biosimilar/synthetic semaglutide non-inferiority in Indian T2DM population; access implications for a high-burden diabetes population where branded GLP-1 therapy remains cost-prohibitive.
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