Efficacy and safety of semaglutide injection in Indian patients with type 2 diabetes mellitus inadequately controlled on metformin: a phase 3, randomized, active-controlled trial (SIZE-DM study).
Semaglutide just got a serious nod for research in India. The SIZE-DM study, a phase 3 trial, stacked up generic semaglutide against the branded version from Novo Nordisk in adults with type 2 diabetes who weren’t hitting targets with metformin alone. Here’s what matters: the generic worked just as well as the original.
Cardiovasc Diabetol Endocrinol Rep
by Kapoor N, Shaikh S, Bhattacharya S et al.
“Efficacy and safety of semaglutide injection in Indian patients with type 2 diabetes mellitus inadequately controlled on metformin: a phase 3, randomized, active-controlled trial (SIZE-DM study). Kapoor N(1), Shaikh S(2), Bhattacharya S(3), Kalra S(4), Das S(5), Kota S(6), Khandelwal V(7), Naskar A(8), Dange A(9), Sorate S(10), Choudhari M(11), Deogaonkar N(12), Shembalkar J(13), Varade D(14), Samadhan SV(15), Somani S(16), Giri R(17), Singh J(18), Palaparthi RK(19), Prasad N(20), Shamanna P(21), Saklecha S(22), Bangar K(23), Mangipudi A(24), Mayabhate M(25), Kapure N(26), Sharma A(26), Vaddem R(26), Jaiswal M(26). Author information: (1)Christian Medical College (CMC), Vellore, Tamil Nadu, India. (2)Prince Aly Khan Hospital, Mumbai, Maharashtra, India. (3)Indraprastha Apollo Hospitals, New Delhi, India. (4)Bharti Hospital, Karnal, Haryana, India. (5)Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha, India. (6)Diabetes & Endocrine Clinic, Berhampur, Odisha, India. (7)Apex Hospital Pvt. Ltd., Jaipur, Rajasthan, India. (8)School of Tropical Medicine, Kolkata, West Bengal, India. (9)Lifepoint Multispecialty Hospital, Pune, Maharashtra, India. (10)Sanjeevani Criticare and Research Centre Pvt. Ltd., Nashik, Maharashtra, India. (11)Ishwar Institute of Health Care, Chhatrapati Sambhajinagar, Maharashtra, India. (12)Deogaonkar Multispeciality Hospital, Nashik, Maharashtra, India. (13)Getwell Hospital and Research Institute, Nagpur, Maharashtra, India. (14)Shree Ashirwad Hospital, Dombivli, Maharashtra, India. (15)Medipoint Hospitals Pvt. Ltd., Pune, Maharashtra, India. (16)Navneet Memorial Hospital "Sushrusha", Ahmedabad, Gujarat, India. (17)G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India. (18)Graduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana, India. (19)Government Siddhartha Medical College, Vijayawada, Andhra Pradesh, India. (20)Sparsh Superspeciality Hospital, Bangalore, Karnataka, India. (21)Bangalore Diabetic Centre, Bangalore, Karnataka, India. (22)Santosh Hospital, Bangalore, Karnataka, India. (23)AIMS Hospital, Dombivli, Maharashtra, India. (24)King George Hospital, Visakhapatnam, Andhra Pradesh, India. (25)Medical Affairs and Clinical Research Division, Alkem Laboratories Ltd., Maharashtra, Mumbai, 400063, India. mayur.mayabhate@alkem.com. (26)Medical Affairs and Clinical Research Division, Alkem Laboratories Ltd., Maharashtra, Mumbai, 400063, India. BACKGROUND: This study evaluated the efficacy and safety of generic semaglutide compared with innovator Semaglutide in Indian adults with type 2 diabetes mellitus (T2DM). METHODS: This Phase 3, multicenter, randomized, active-controlled, non-inferiority trial enrolled 320 adults with T2DM inadequately controlled on metformin. Participants were randomized 1:1 to receive either generic semaglutide (Alkem laboratories Ltd.) or innovator Inj. semaglutide (Novo Nordisk) for 24 weeks in step-wise dose escalation from 0.25 mg/week to 2 mg/week. The primary endpoint was change in HbA1c from baseline to Week 24. Secondary endpoints included changes in fasting and post-prandial glucose, body weight, and proportion of patients achieving HbA1c < 7.0%. Safety assessments included adverse events, hypoglycemia, various laboratory parameters. RESULTS: Of 320 participants randomized, 313 completed the study. Baseline demographic and clinical characteristics were comparable between groups. At Week 24, both treatments achieved significant HbA1c reductions (mean - 2.20%), with generic semaglutide demonstrating non-inferiority to the reference. Reductions in body weight, fasting and post-prandial glucose were similar between arms. A total of 86.62% of participants achieved HbA1c < 7.0%. Safety profiles were comparable, with predominantly mild-to-moderate adverse events and no treatment-related serious adverse events. CONCLUSION: Generic semaglutide demonstrated non-inferior efficacy and comparable safety to innovator Semaglutide in Indian adults with T2DM inadequately controlled on metformin, offering an effective and accessible therapeutic option in resource-limited settings. © 2026. The Author(s). Conflict of interest statement: Declarations. Ethical approval: The study protocol was reviewed and approved by the Institutional Ethics Committees. All procedures were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the principles of the Declaration of Helsinki (revised 2024). Written informed consent was obtained from all individual participants prior to enrolment. Competing interests: Vipul Khandelwal, Arindam Naskar, Amol Dange, Sanket Sorate, Mayura Choudhari, Narayan Deogaonkar, Jayashree Shembalkar, Deepak Varade, Shejole Vivek Samadhan, Shrikant Somani, Richa Giri, Jasminder Singʳ, Rajesh Kumar Palaparthi, Narendra Prasad, Paramesh Shamanna, Santosh Saklecha, Kushal Bangar and Aruna Mangipudi received grants in support of investigator for this study, while Mayur Mayabhate, Nitin Kapure, Akhilesh Sharma, Radhakrishna Vaddem and Mukesh Jaiswal are employees of Alkem Laboratories Ltd. Nitin Kapoor, Shehla Shaikh, Saptarshi Bhattacharya, Sanjay Kalra, Sambit Das and Sunil Kota have no conflict of interest.”
Researchers randomized 320 participants across multiple centers. Both groups went through a 24-week protocol, starting at 0.25 mg/week and ramping up to 2 mg/week. The main metric was HbA1c change at 24 weeks. Both versions of semaglutide nailed it, with average HbA1c dropping by 2.2%. That’s not a subtle effect—most participants (over 86%) reached an HbA1c under 7.0%.
Key findings:
Generic semaglutide from Alkem delivered non-inferior efficacy to the reference
Fasting and post-meal glucose, as well as body weight, dropped similarly in both groups
Safety? No red flags. Mild-to-moderate events only, no serious issues reported
For researchers, this means the Indian-made version of semaglutide is now a legitimate candidate for future studies or resource-limited settings. The safety and efficacy profile matched the innovator product, which could open up wider access and more cost-effective research options.
Curious about sourcing semaglutide for benchwork? Check the semaglutide page for details, or hit the vendor directory for options.
Bottom line: semaglutide research just got easier and more affordable in India, with evidence to back it up.
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