Abstract Objectives To evaluate the efficacy and safety of Synthetic Semaglutide Injection manufactured by Sun Pharma (Test arm) with Ozempic® Injection (Reference arm) in Indian patients with Type 2 Diabetes Mellitus (T2DM) in three subgroups based on BMI: <23 kg/m2 (Subgroup 1 [S1]), 23 to <25 kg/m2 (Subgroup 2 [S2]), ≥25 kg/m2 (Subgroup 3 [S3]). Materials and Methods This was a phase III, multicentre, randomized, open-label, active controlled study. Total 314 adults (18-65 years) with T2DM (HbA1c: 7.0-10.5%) on diet/exercise uncontrolled with stable metformin dose (≥1500 mg or maximum tolerated dose) for ≥12 weeks were enrolled. Eligible patients were randomized in a 1:1 ratio and received Test product or Reference product, subcutaneous injections in a weekly dose of 0.25 mg to 2 mg for 24 weeks. [CTRI Registration number: CTRI/2025/02/080592]. Results At baseline, distribution of patients was as follows: 38 patients with BMI <23 kg/m2(S1), 72 patients with BMI 23 to <25 kg/m2(S2) and 204 patients with BMI ≥25 kg/m2(S3). HbA1c reduction from baseline to Week 24 in Test arm was comparable to comparator arm: S1: −2.26 ± 0.91% vs −1.89 ± 0.87% (P = .2028), S2: −2.21 ± 0.76% vs −2.25 ± 0.74% (P = .9033), S3: −1.95 ± 0.82% vs −1.85 ± 0.95% (P = .4848). Significant reduction from baseline HbA1c was observed across all three sub-groups at Week 24 in both the study arms. Significant reductions in post-prandial and fasting blood glucose levels at Week 24 were seen in both the study arms and the changes were comparable across all three BMI subgroups. Proportion of patients achieving HbA1c <7.0% were comparable between the Test and Comparator arms, S1:15 (88.2%) vs 13 (76.5%) (P = .3697), S2: 23 (74.2%) vs 27 (75.0%) (P = .7267), S3: 68 (72.3%) vs 68 (73.1%) (P = .9184) across all three BMI subgroups. Three patients experienced hypoglycaemia. None of the patients required rescue medication. The incidence of treatment-emergent adverse events (TEAEs) was similar in both arms. Most common TEAEs were gastrointestinal events (Diarrhoea, Nausea, Vomiting) in all three subgroups. Study medications were well tolerated. Conclusions Semaglutide injection (Test product) demonstrated comparable glycaemic control to Reference product in T2DM patients uncontrolled on metformin monotherapy across all three BMI subgroups of normal weight, overweight and obese patients.
Abstract Objectives To evaluate the efficacy and safety of Synthetic Semaglutide Injection manufactured by Sun Pharma (Test arm) with Ozempic® Injection (Reference arm) in Indian patients with Type 2 Diabetes Mellitus in three subgroups based on Age: <40 years (Subgroup 1 [S1]), 40 to <50 years (Subgroup 2 [S2]), ≥50 years (Subgroup 3 [S3]) Materials and Methods This was a phase III, multicentre, randomized, open-label, active controlled study. Total 314 adults (18-65 years) with T2DM (HbA1c: 7.0-10.5%) on diet/exercise uncontrolled with stable metformin dose (≥1500 mg or maximum tolerated dose) for ≥12 weeks were enrolled. Eligible patients were randomized in a 1:1 ratio and received Test product or Reference product, subcutaneous injections in a weekly dose of 0.25 mg to 2 mg for 24 weeks. [CTRI Registration number: CTRI/2025/02/080592] Results At baseline, distribution of patients was as follows: 54 patients aged <40 years (S1), 107 patients aged 40 to <50 years (S2) and 153 patients aged ≥50 years (S3). HbA1c reduction (±SD) from baseline to Week 24 in Test arm was comparable to Reference arm across all 3 age subgroups: S1: −1.85 ± 0.70% vs—2.20 ± 0.80% (P = .2220), S2:—2.05 ± 0.87% vs −1.92 ± 0.96% (P = .4542), S3: −2.10 ± 0.83% vs −1.88 ± 0.90% (P = .1557). Significant reduction from baseline in HbA1c was observed across all three sub-groups at Week 24 in both the study arms. Significant reductions in post-prandial and fasting blood glucose levels at Week 24 were seen in both study arms and the changes were comparable across all three age subgroups. Proportion of patients achieving HbA1c <7.0% were comparable between the Test and Reference arms, S1: 19 (86.4%) vs 24 (82.8%) (P = .3426), S2: 36 (72.0%) vs 34 (70.8%) (P = .8843), S3: 51 (72.9%) vs 50 (72.5%) (P = .6315) across all three age subgroups. Three patients experienced hypoglycaemia. None of the patients required rescue medication. The incidence of treatment-emergent adverse events (TEAEs) was similar in both arms. Most common TEAEs were gastrointestinal events (Diarrhoea, Nausea, Vomiting) in all three subgroups. Study medications were well tolerated. Conclusions Semaglutide injection (Test Product) demonstrated comparable glycaemic control to Reference product in T2DM patients uncontrolled on metformin monotherapy across all age groups.
Abstract Objectives To evaluate the efficacy and safety of Synthetic Semaglutide Injection manufactured by Sun Pharma (Test arm) with Ozempic® Injection (Reference arm) in Indian patients with type 2 diabetes mellitus (T2DM) with mild renal impairment (eGFR 60 to <90 mL/min/1.73 m2). Materials and Methods This was a phase III, multicentre, randomized, open-label, active controlled study. Total 314 adults (18-65 years) with T2DM (HbA1c: 7.0-10.5%) on diet/exercise uncontrolled with stable metformin dose (≥1500 mg or maximum tolerated dose) for ≥12 weeks were enrolled. Eligible patients were randomized in a 1:1 ratio and received Test product (manufactured by Sun Pharma) or Reference product, subcutaneous injections in a weekly dose of 0.25 mg to 2 mg for 24 weeks. [CTRI Registration number: CTRI/2025/02/080592]. Results This subgroup analysis included total 109 patients (Test arm [n=55] and Reference arm[n=54]) with mild renal impairment (eGFR 60 to <90 mL/min/1.73 m2). HbA1c reduction (± SD) from baseline to Week 24 was comparable to comparator in this subgroup: −1.95 ± 0.72% vs −1.77 ± 0.88% (P = .3920). Significant reduction from baseline HbA1c was observed in both test arm and reference arm at Week 24. Significant reductions in post-prandial and fasting blood glucose levels at Week 24 were seen in both the study arms and the changes were comparable in this subgroup. Proportion of patients achieving HbA1c <7.0% from baseline to Week 24 were comparable between the Test arm and reference arm 42 (76.4%) vs 42 (77.8%) (P = .7191). One patient experienced hypoglycaemia. None of the patients required rescue medication. The incidence of treatment-emergent adverse events (TEAEs) was similar in both arms (Test arm = 66.2% and Reference arm = 69.5%). Most common TEAEs were gastrointestinal events (Diarrhoea, Nausea, Vomiting). Study medications were well tolerated. Conclusions Semaglutide injection (Test Product) demonstrated comparable glycaemic control to Reference product in T2DM patients uncontrolled on metformin monotherapy with mild renal impairment.
