A Phase III, Randomized, Double-Blind Clinical Trial of a Novel Triple Fixed-Dose Combination (Glimepiride/Vildagliptin/Metformin) in Mexican Adults with Uncontrolled Type 2 Diabetes After Dual Oral Therapy Failure
Abstract
Background: : /Objectives: Achieving glycaemic control remains challenging in patients with type 2 diabetes mellitus (T2DM). Fixed-dose combinations with complementary mechanisms may facilitate treatment intensification and improve adherence. This study evaluated the efficacy and safety of a dose-titrated fixed-dose combination (FDC) of glimepiride, vildagliptin, and metformin in this population.
Methods:: This phase III, randomized, double-blind, multicentre clinical trial enrolled adults with in-adequate glycaemic control after dual oral therapy. Participants initiated low-dose FDC once daily. On days 45 and 90, those with a glycated haemoglobin (HbA1c) re-duction ≤0.3% were escalated to intermediate-dose FDC or high-dose FDC according to their randomized pathway. The primary endpoint was the change in HbA1c from baseline to day 180.
Results:: FDC produced clinically and statistically significant HbA1c reductions, with glycaemic improvement evident by day 45. At the end of follow-up, 52.4% achieved HbA1c < 7.0%: 24.1% with low-dose FDC, 12.0% after escala-tion to intermediate-dose FDC, and 16.3% with high-dose FDC. Overall, 133 adverse events occurred in 62 participants; 54.9% were mild, and none were severe. Hypoglycaemia (13.5%; n=18) and headache (8.3%; n=11) were the most frequent events.
Conclusions:: FDC improved glycaemic control after failure of dual therapy and was generally well tolerated, supporting response-guided dose escalation. These findings indicate that…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 62 participants or records.
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