Generic Semaglutide Injection Non-Inferior to Ozempic for Glycemic Control in Indian Type 2 Diabetes Patients

Managing Type 2 Diabetes Mellitus (T2DM) remains a significant challenge globally, particularly in regions like India where obesity and diabetes prevalence are rising. Current standard-of-care often includes metformin, but many patients require additional therapies to achieve optimal glycemic control. Glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide are highly effective, offering substantial reductions in HbA1c and body weight. However, the high cost of innovator drugs can limit access, creating a critical need for equally effective and safe generic alternatives to improve patient outcomes and healthcare accessibility.

This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study enrolled 314 Indian adults (18-65 years) with T2DM and baseline HbA1c between 7.0% and 10.5%, despite stable metformin therapy and diet/exercise. Patients were randomised (1:1) to receive subcutaneous injections of either Test semaglutide or Reference semaglutide (Ozempic) once weekly for 24 weeks. An identical dose-escalation regimen was used, starting from 0.25 mg and increasing to 2.0 mg per week. The primary endpoint was the change in HbA1c from baseline to Week 24, with secondary endpoints including changes in fasting/post-prandial blood glucose, body weight, and safety.

At Week 24, both Test semaglutide and Reference semaglutide produced significant and comparable reductions in HbA1c from baseline. The Test group showed a mean reduction of -2.04%, while the Reference group achieved -1.95% (p < 0.0001 within both groups). The least-squares mean difference (Test-Reference) was -0.09% (95% CI: -0.26 to 0.09), successfully meeting the pre-specified non-inferiority criterion. Improvements in fasting and post-prandial blood glucose, the proportion of patients achieving HbA1c < 7.0%, and body weight reductions were similar between the two treatment arms. Safety profiles were also comparable, with the most common treatment-emergent adverse events being mild-to-moderate gastrointestinal events (Test vs. Reference: 43.3% vs. 46.5%). No anti-drug or neutralising antibodies were detected in either group.

The Test synthetic semaglutide injection demonstrated non-inferior glycaemic efficacy and comparable safety to Reference semaglutide, with an HbA1c difference of only -0.09%.