Sitagliptin, Metformin and Glimepiride Fixed-Dose Combination Compared to Co-Administration of Metformin and High-Dose Glimepiride in Indian Patients With Type 2 Diabetes: A Randomised, Double-Blind, Double-Dummy, Phase 3 Clinical Study
Abstract
Aims: This study assessed the efficacy and safety of a triple fixed-dose combination (FDC) of sitagliptin, metformin, and glimepiride versus co-administered metformin and glimepiride in Indian patients with uncontrolled Type 2 diabetes (T2D).
Materials and methods: In this Phase 3, randomised, double-blind, double-dummy study, adult patients with T2D and glycated haemoglobin (HbA1c) of 8%-11%, despite treatment with metformin and glimepiride, were randomised 1:1 to triple FDC of sitagliptin 50 mg, metformin 1000 mg and glimepiride 1 mg (SITA + MET + GLIM group) or metformin 1000 mg and glimepiride 2 mg (Co-administration group) for 16 weeks. Patients assigned to the SITA + MET + GLIM group could continue treatment for a 12-week open-label period. The primary endpoint was the change in HbA1c from baseline to Week 16.
Results: Overall, 190 patients were randomised to the SITA + MET + GLIM group and 202 to the Co-administration group. The least squares mean (standard error) change from baseline in HbA1c at Week 16 was -1.79 (0.07%) in the SITA + MET + GLIM group and -1.27 (0.06%) in the co-administration group (estimated treatment difference -0.51; 95% confidence interval [CI] -0.69 to -0.33; p 1c below 7% at Week 16 was 32.1% in the SITA + MET + GLIM group and 12.6% in the Co-administration group (p < 0.0001). Adverse events occurred in 25 patients (13.2%) in the SITA + MET + GLIM group and 30 patients (14.9%) in the Co-administration group.
Conclusions: The triple FDC was…
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: 190 participants or records.
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