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Background <p>This study evaluated the efficacy and safety of generic semaglutide compared with innovator Semaglutide in Indian adults with type 2 diabetes mellitus (T2DM).</p> Methods <p>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&#xa0;mg/week to 2&#xa0;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 &lt; 7.0%. Safety assessments included adverse events, hypoglycemia, various laboratory parameters.</p> Results <p>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 &lt; 7.0%. Safety profiles were comparable, with predominantly mild-to-moderate adverse events and no treatment-related serious adverse events.</p> Conclusion <p>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.</p>

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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)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月24日

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  • Nitin Kapoor,
  • Shehla Shaikh,
  • Saptarshi Bhattacharya,
  • Sanjay Kalra,
  • Sambit Das,
  • Sunil Kota,
  • Vipul Khandelwal,
  • Arindam Naskar,
  • Amol Dange,
  • Sanket Sorate,
  • Mayura Choudhari,
  • Narayan Deogaonkar,
  • Jayashree Shembalkar,
  • Deepak Varade,
  • Shejole Vivek Samadhan,
  • Shrikant Somani,
  • Richa Giri,
  • Jasminder Singh,
  • Rajesh Kumar Palaparthi,
  • Narendra Prasad,
  • Paramesh Shamanna,
  • Santosh Saklecha,
  • Kushal Bangar,
  • Aruna Mangipudi,
  • Mayur Mayabhate,
  • Nitin Kapure,
  • Akhilesh Sharma,
  • Radhakrishna Vaddem,
  • Mukesh Jaiswal

摘要

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.