Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III , Active‐Controlled Study
Primary result · Change in HbA1c from baselineResult — go to the resultLeast-squares mean difference −0.09 % 95% CI −0.26 to 0.09Authors' conclusion
The Test synthetic semaglutide injection demonstrated non-inferior glycaemic efficacy, comparable safety in comparison to Reference semaglutide
Study context
- Population
- Indian adults aged 18–65 years with T2D and HbA1c ≥ 7.0% to ≤ 10.5% despite stable metformin and diet & exercise; 35 centres in India290 completed
- Participants
- 314 adults
- Comparison
- Test synthetic semaglutide vs Reference semaglutide (Ozempic), once weekly for 24 weeks
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsphase III, open-label, multicentre, parallel-group, active-controlled, non-inferiority
- Phase III
- Open-label
- Multicentre
- Parallel-group
- Active-controlled
- Non-inferiority
Primary result
As reported in the abstract
Least-squares mean difference
−0.09 %
95% CI −0.26 to 0.09
Change by group
Test
−2.04
%
Reference
−1.95
%
Testvs Reference
least-squares mean difference −0.09 % (95% CI −0.26 to 0.09)
- Significant reduction in HbA1c within each group
- P < 0.0001 within groups
Secondary outcomes
Fasting and post-prandial blood glucose, HbA1c < 7.0% achievers, bodyweight
- Improvements similar between the two groups
Safety
Most common TEAEs: predominantly mild-to-moderate gastrointestinal events
Immunogenicity
- No anti-drug or neutralising antibodies were detected
Original publication
Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III , Active‐Controlled Study. Diabetes Obes Metab. Published 31 May 2026. doi:10.
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