Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III, Active-Controlled Study.
Semaglutide just went head-to-head with itself in Indian Type 2 diabetes research—and the new synthetic version held its ground. Researchers ran a 24-week, phase III, randomized trial across 35 sites, comparing a test semaglutide injection to the established reference formulation (Ozempic) in adults who weren’t getting enough from metformin alone.
Diabetes Obes Metab
by Ambika Gopalakrishnan U, Joshi AS, Giri R et al.
“Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III, Active-Controlled Study. Ambika Gopalakrishnan U(1), Joshi AS(2), Giri R(3), Shah SJ(4), Shukla J(5), Maheshwari S(6), M Chowdaiah R(7), Singh MK(8), Bari AS(9), Pathak NP(10), Shah AN(11), Bhandari S(12), Gowda A(13), Chandrappa A(14), Supe PD(15), Das B(16), Sharma PK(17), Virani MK(18), Kurmi PH(19), Ghanekar GA(20), Dasari MD(21), Sahoo B(22), Jangid SK(23), Shende PS(24), Patil SS(25), Kumbhar AN(26), Deshpande SV(27), Chennappa M(28), Patel NC(29), Sonawane D(30), Patil D(30), Pandit S(30), Ghadge P(30), Mehta S(30). Author information: (1)Chellaram Diabetes Institute, Pune, Maharashtra, India. (2)Bhaktivedanta Hospital and Research Institute, Thane, Maharashtra, India. (3)GSVM Medical College, Kanpur, Uttar Pradesh, India. (4)Ratan Multi-Speciality Hospital, Ahmedabad, Gujarat, India. (5)Motilal Nehru Medical College, Prayagraj, Uttar Pradesh, India. (6)Jawahar Lal Nehru Medical College, Ajmer, Rajasthan, India. (7)Mandya Institute of Medical Science, Mandya, Karnataka, India. (8)Maya Hospital and Maternity Centre, Kanpur, Uttar Pradesh, India. (9)Pulse Multispeciality Hospital, Pune, Maharashtra, India. (10)Ojas Multispeciality Hospital, Pune, Maharashtra, India. (11)Health 1 Super Speciality Hospital, Ahmedabad, Gujarat, India. (12)Vincare Hospital, Bathinda, Punjab, India. (13)Citizen Hospital, Bangalore, Karnataka, India. (14)Medstar Speciality Hospital, Bangalore, Karnataka, India. (15)Supe Heart & Diabetes Hospital & Research Centre, Nashik, Maharashtra, India. (16)Sparsh Hospitals and Critical Care, Bhubaneswar, Odisha, India. (17)Maharaja Agrasen Superspeciality Hospital, Jaipur, Rajasthan, India. (18)Global Hospital, Surat, Gujarat, India. (19)Shivam Hospital, Ahmedabad, Gujarat, India. (20)Asian Institute of Medical Sciences, Dombivli, Maharashtra, India. (21)Rajalakshmi Hospital & Research Center, Bangalore, Karnataka, India. (22)Kanungo Institute of Diabetes Specialities, Bhubaneshwar, Odisha, India. (23)Hi-Tech Medical College & Hospital, Bhubaneswar, Odisha, India. (24)Lokmanya Medical Research Center, Pune, Maharashtra, India. (25)Shree Siddhivinayak Maternity & Nursing Home, Nashik, Maharashtra, India. (26)Aster Aadhar Hospital (Prerna Hospital), Kolhapur, Maharashtra, India. (27)Ashirwad Hospital and Research Centre, Ulhasnagar, Maharashtra, India. (28)NRR Hospital, Bangalore, Karnataka, India. (29)Samarpan Hospital, Ahmedabad, Gujarat, India. (30)Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India. 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 & exercise control were randomised (1:1) to receive subcutaneous injections of Test semaglutide or Reference semaglutide once weekly for 24 weeks, using an identical dose-escalation regimen (from 0.25 to 2.0 mg per week). The primary endpoint was change in HbA1c from baseline to Week 24. Secondary endpoints included changes in fasting and post-prandial blood glucose, bodyweight and HbA1c < 7.0% achievers, safety and immunogenicity. RESULTS: A total of 314 patients were randomised, and 290 patients completed the study. At Week 24, both treatments produced significant and comparable reductions in HbA1c (Test: -2.04%, Reference: -1.95%; 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=. © 2026 Sun Pharma Laboratories Limited. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.”
Both versions of semaglutide brought down HbA1c by about 2% over six months. That’s solid glycemic control, and the difference between the test and reference groups was basically zero (just -0.09% in least-squares mean change). Fasting and post-meal blood sugar? Also similar. Weight loss and the percentage of patients dropping below the 7% HbA1c target—no surprises there either.
Safety looked nearly identical. Around 45% of patients had mild or moderate GI side effects (think nausea, but manageable), with no meaningful difference between the two groups. Nobody developed anti-drug or neutralizing antibodies, which is a green flag for immunogenicity.
Key takeaway: A synthetic semaglutide injection made outside the big-name pipeline can be just as effective and safe as the original Ozempic formulation—at least in this population. For researchers, this opens more doors for sourcing semaglutide and studying its effects in diverse groups. It’s a win for accessibility and for anyone building a broader toolkit for peptide research.
Want to keep tabs on where to find trusted sources? Check the vendor directory for semaglutide suppliers and other research compounds. Peptide science keeps moving. This study shows how alternative manufacturing and robust clinical evaluation can expand the playground for serious research.
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