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ABSTRACT Aim To evaluate the efficacy, safety and immunogenicity of semaglutide injection (synthetic) (Test group) compared with the Reference semaglutide injection Ozempic, (Reference group) in Indian patients with Type 2 diabetes mellitus (T2DM). Materials and Methods This Phase III, randomised, open‐label, multi‐centre, parallel‐group, active‐controlled non‐inferiority study was conducted across 35 centres in India. Adults aged 18–65 years with T2DM and baseline glycated haemoglobin (HbA1c) ≥ 7.0% to ≤ 10.5% despite stable metformin therapy and diet p < 0.0001 within groups). The least‐squares mean difference (Test‐Reference) was −0.09% (95% CI: −0.26 to 0.09), meeting the pre‐specified non‐inferiority criterion. Improvements in fasting and post‐prandial blood glucose, patients achieving HbA1c < 7.0% and bodyweight were similar between the two groups. The most common treatment‐emergent adverse events were predominantly mild‐to‐moderate gastrointestinal events (Test vs. Reference: 43.3% vs. 46.5%). No anti‐drug or neutralising antibodies were detected. Conclusions The Test synthetic semaglutide injection demonstrated non‐inferior glycaemic efficacy, comparable safety in comparison to Reference semaglutide, supporting its use as an effective therapeutic option for patients with T2DM. Prospectively registered on the Clinical Trials Registry—India, CTRI/2025/02/080592 Registered on: 14/02/2025, URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIwODUw&Enc=&userName= .
Gopalakrishnan et al. (Sun,) studied this question.