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Study · Randomized controlled trial · n = 290 · 2026

8 results

Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III, Active-Controlled Study.

Ambika Gopalakrishnan U, Joshi AS, Giri R, Shah SJ, Shukla J, Maheshwari S, M Chowdaiah R, Singh MK, Bari AS, Pathak NP, Shah AN, Bhandari S and 22 more

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Gowda A, Chandrappa A, Supe PD, Das B, Sharma PK, Virani MK, Kurmi PH, Ghanekar GA, Dasari MD, Sahoo B, Jangid SK, Shende PS, Patil SS, Kumbhar AN, Deshpande SV, Chennappa M, Patel NC, Sonawane D, Patil D, Pandit S, Ghadge P, Mehta S

Diabetes, obesity & metabolism31 May 2026Cited by 3 (Europe PMC)

PMID42219226 (opens in a new tab)PMCIDPMC13341390 (opens in a new tab)DOI10.1111/dom.70891 (opens in a new tab)PepBankPUB-42219226
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Indian adults with type 2 diabetes on metformin, both synthetic (Test) and Reference semaglutide significantly reduced HbA1c at week 24, with comparable reductions.

    In plain wordsIn Indian adults with type 2 diabetes, both the synthetic and the reference semaglutide lowered HbA1c by a similar amount over 24 weeks.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change from baseline to week 24
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −2.04%
    Test semaglutide
    HbA1c change
    −1.95%
    Reference semaglutide

    Source sentences

    Summary
    At Week 24, both treatments produced significant and comparable reductions in HbA1c (Test: -2.04%, Reference: -1.95%; p < 0.0001 within groups).
    3 context sentences
    Summary · context
    The primary endpoint was change in HbA1c from baseline to Week 24.
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Indian adults with type 2 diabetes, the least-squares mean HbA1c difference between Test and Reference semaglutide was -0.09% (95% CI -0.26 to 0.09), meeting the non-inferiority criterion.

    In plain wordsIn Indian adults with type 2 diabetes, synthetic semaglutide lowered HbA1c about as well as the reference semaglutide, meeting the non-inferiority goal.

    Peptide
    Semaglutide
    Outcome
    No significant changeHbA1c difference between Test and Reference (non-inferiority)
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    LS mean difference in HbA1c (Test-Reference)
    −0.09%
    week 24

    Source sentences

    Summary
    The least-squares mean difference (Test-Reference) was -0.09% (95% CI: -0.26 to 0.09), meeting the pre-specified non-inferiority criterion.
    2 context sentences
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Indian adults with type 2 diabetes, improvement in fasting blood glucose was similar between Test and Reference semaglutide.

    In plain wordsIn Indian adults with type 2 diabetes, fasting blood sugar improved by a similar amount with synthetic and reference semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changeFasting blood glucose improvement
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Improvements in fasting and post-prandial blood glucose, patients achieving HbA1c < 7.0% and bodyweight were similar between the two groups.
    3 context sentences
    Summary · context
    Secondary endpoints included changes in fasting and post-prandial blood glucose, bodyweight and HbA1c < 7.0% achievers, safety and immunogenicity.
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Indian adults with type 2 diabetes, improvement in post-prandial blood glucose was similar between Test and Reference semaglutide.

    In plain wordsIn Indian adults with type 2 diabetes, blood sugar after meals improved by a similar amount with synthetic and reference semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changePost-prandial blood glucose improvement
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Improvements in fasting and post-prandial blood glucose, patients achieving HbA1c < 7.0% and bodyweight were similar between the two groups.
    3 context sentences
    Summary · context
    Secondary endpoints included changes in fasting and post-prandial blood glucose, bodyweight and HbA1c < 7.0% achievers, safety and immunogenicity.
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Indian adults with type 2 diabetes, the proportion of patients achieving HbA1c < 7.0% was similar between Test and Reference semaglutide.

    In plain wordsIn Indian adults with type 2 diabetes, a similar share of people reached HbA1c below 7.0% with synthetic and reference semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changeProportion achieving HbA1c < 7.0%
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Improvements in fasting and post-prandial blood glucose, patients achieving HbA1c < 7.0% and bodyweight were similar between the two groups.
    3 context sentences
    Summary · context
    Secondary endpoints included changes in fasting and post-prandial blood glucose, bodyweight and HbA1c < 7.0% achievers, safety and immunogenicity.
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Indian adults with type 2 diabetes, body weight improvement was similar between Test and Reference semaglutide.

    In plain wordsIn Indian adults with type 2 diabetes, body weight changed by a similar amount with synthetic and reference semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changeBody weight change
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Improvements in fasting and post-prandial blood glucose, patients achieving HbA1c < 7.0% and bodyweight were similar between the two groups.
    3 context sentences
    Summary · context
    Secondary endpoints included changes in fasting and post-prandial blood glucose, bodyweight and HbA1c < 7.0% achievers, safety and immunogenicity.
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…
  7. 07HumanRandomized controlled trialSafety outcome

    In Indian adults with type 2 diabetes, the most common treatment-emergent adverse events were mostly mild-to-moderate gastrointestinal events, 43.3% with Test versus 46.5% with Reference semaglutide.

    In plain wordsIn Indian adults with type 2 diabetes, mostly mild stomach and gut side effects occurred at similar rates with synthetic (43.3%) and reference (46.5%) semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changeTreatment-emergent gastrointestinal adverse events
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Treatment-emergent adverse event rate (predominantly gastrointestinal)
    43.3%
    Test semaglutide
    Treatment-emergent adverse event rate (predominantly gastrointestinal)
    46.5%
    Reference semaglutide

    Source sentences

    Summary
    The most common treatment-emergent adverse events were predominantly mild-to-moderate gastrointestinal events (Test vs. Reference: 43.3% vs. 46.5%).
    2 context sentences
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…
  8. 08HumanRandomized controlled trialSafety outcome

    In Indian adults with type 2 diabetes, no anti-drug or neutralising antibodies were detected with Test or Reference semaglutide.

    In plain wordsIn Indian adults with type 2 diabetes, no antibodies against synthetic or reference semaglutide were found.

    Peptide
    Semaglutide
    Outcome
    No significant changeImmunogenicity: anti-drug and neutralising antibodies
    Study

    n = 290

    Comparator
    Reference semaglutide injection (Ozempic)
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    0.25 to 2.0 mg per week · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    No anti-drug or neutralising antibodies were detected.
    2 context sentences
    Summary · context
    This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India.
    Summary · context
    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 identica…

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:04 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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