Trial reportJournal of diabetes2026
Efficacy and Safety of Glimepiride, Voglibose, and Metformin ER in Type 2 Diabetes: A Randomized, Active-Controlled Study.
Trial report in Journal of diabetes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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21 authors.
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Abstract
backgroundIndia ranks second in the global diabetes epidemic, with about 89 million individuals living with Type 2 diabetes mellitus (T2DM). We compared the efficacy and safety of fixed-dose combination (FDC) of glimepiride, voglibose, and extended-release metformin (GLIME+VOGLI+MET-ER) with voglibose and metformin (VOGLI+MET) and glimepiride and metformin (GLIME+MET).
methodsA Phase IV, randomized, open-label, active-controlled study was performed in adult patients with T2DM poorly controlled with metformin. Patients received twice daily doses of GLIME+VOGLI+MET-ER (1 + 0.2 + 500 mg: Trivolib 1, 2 + 0.2 + 500 mg: Trivolib 2); or VOGLI+MET (0.2 + 500 mg, 0.3 + 500 mg) or GLIME+MET (1 + 500 mg, 2 + 500 mg). The primary endpoint was the change in HbA1c from baseline.
resultsOf the 458 patients screened, 399 were randomized (GLIME+VOGLI+MET-ER [n = 133], VOGLI+MET (n = 135), and GLIME+MET [n = 131]). The mean baseline HbA1c was ~8.35% (~67.77 mmol/mol). All the treatments showed a significant reduction in HbA1c at Weeks 12 and 24. Mean change in % (mmol/mol) HbA1c was significantly more with GLIME+VOGLI+MET-ER versus VOGLI+MET and GLIME+MET at Week 12 (-1.02 ± 0.60 [-11.2 ± 6.52] vs. -0.68 ± 0.64 [-7.49 ± 6.95], p < 0.001 and -0.88 ± 0.49 [-9.65 ± 5.34], p = 0.0154) and Week 24 (-1.57 ± 0.74 [-17.2 ± 8.14] vs. -1.11 ± 0.80 [-12.2 ± 8.79], p < 0.001 and -1.28 ± 0.60 [-14.0 ± 6.56], p = 0.0002). Overall, 49 adverse events (AEs) were reported in 32/399 (8.0%) patients. One patient each in GLIME+VOGLI+MET-ER and VOGLI+MET groups had level 1 hypoglycemia requiring no management. No severe or serious AEs were reported.
conclusionsIn adult patients with T2DM inadequately controlled on metformin monotherapy, GLIME+VOGLI+MET-ER demonstrated superior HbA1c reduction compared with VOGLI+MET and GLIME+MET at Weeks 12 and 24. Study medications were safe and well-tolerated.
trial registrationClinical Trial Registry India-CTRI/2020/11/029080 [Registered on: 12/11/2020].
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