Triple Therapy Shows Superior Glycemic Control compared to metformin monotherapy: Study
In adults with type 2 diabetes inadequately controlled on metformin alone, the combination of glimepiride, voglibose, and metformin ER achieved greater HbA1c reduction at 12 and 24 weeks compared to dual therapies (voglibose + metformin or glimepiride + metformin). All treatment regimens were found to be safe and well tolerated.
India 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).
A 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.
Of 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.
In 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.
Reference:
B.Mohan, S. V.Kumar, P. H.Kurmi, et al., “Efficacy and Safety of Glimepiride, Voglibose, and Metformin ER in Type 2 Diabetes: A Randomized, Active-Controlled Study,” Journal of Diabetes18, no. 4 (2026): e70217, https://doi.org/10.1111/1753-0407.70217.
Keywords:
Triple Therapy, Shows, Superior, Glycemic, Control, compared, metformin monotherapy, Study,B.Mohan, S. V.Kumar, P. H.Kurmi
