Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III, Active-Controlled Study - PubMed

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Aim of the study was to evaluate efficacy, safety, and immunogenicity of a test synthetic semaglutide injection compared to a reference semaglutide (Ozempic) in Indian patients with type 2 diabetes mellitus.
This was a Phase III, randomized, open-label, multi-centre, active-controlled non-inferiority trial across 35 centres in India, with 314 randomized patients and 290 completers.
Both test and reference semaglutide showed significant and comparable reductions in HbA1c at Week 24 (test: -2.04%, reference: -1.95%), meeting the non-inferiority criterion with a least-squares mean difference of -0.09%.
Secondary endpoints including fasting and post-prandial blood glucose improvements, HbA1c <7.0% achievers, and bodyweight changes were similar between groups.
Safety profiles were comparable, with predominantly mild-to-moderate gastrointestinal adverse events, and no anti-drug or neutralizing antibodies were detected.
The test synthetic semaglutide injection demonstrated non-inferior glycaemic efficacy and comparable safety, supporting its use as an effective therapeutic option for type 2 diabetes mellitus.

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