Sitagliptin-Based Triple FDC Achieves Greater HbA1c Reduction Than Metformin Plus Glimepiride in Indian Diabetics: Study

A new study published in the journal of Diabetes Obesity and Metabolism showed that a triple fixed-dose combination containing sitagliptin provides a larger reduction in HbA1c levels when compared to a combination of metformin and glimepiride in diabetic patients in India.

The amalgamation of sitagliptin, metformin, and a low dosage of glimepiride could potentially enhance blood sugar control, diminish the risk of hypoglycemia, and maintain the function of pancreatic beta cells. This clinical trial assessed the effectiveness and safety of this triple fixed-dose combinations (FDCs) therapy when compared to a regimen of metformin combined with a high dose of glimepiride among Indian patients with unregulated type 2 diabetes (T2D).

In this Phase 3 trial, adults diagnosed with T2D and glycated hemoglobin (HbA1c) levels between 8% and 11%, despite being treated with metformin and glimepiride, were divided equally into two groups. One group received a triple FDC of sitagliptin 50 mg, metformin 1000 mg, and glimepiride 1 mg (referred to as the SITA + MET + GLIM group), while the other group received metformin 1000 mg and glimepiride 2 mg together (known as the Co‐administration group) for a duration of 16 weeks. Patients in the SITA + MET + GLIM group had the option to extend their treatment during a 12-week open-label phase. The main goal was to observe the alteration in HbA1c levels from the beginning of the study to Week 16.

In total, 190 individuals were assigned to the SITA + MET + GLIM group, while 202 were allocated to the Co‐administration group. The average change in HbA1c from the starting point at Week 16 was -1.79 (0.07%) for the SITA + MET + GLIM group and -1.27 (0.06%) for the co‐administration group, with a calculated treatment difference of -0.51; the confidence interval was -0.69 to -0.33, and the p-value was less than 0.0001.

At Week 16, 32.1% of patients in the SITA + MET + GLIM group had HbA1c levels below 7%, when compared to 12.6% in the Co‐administration group (p < 0.0001). Adverse effects were reported in 25 individuals (13.2%) in the SITA + MET + GLIM group and 30 individuals (14.9%) in the Co‐administration group. Overall, this research indicated that the triple fixed-dose combination is efficient, well-received, and shows promise in decreasing the number of pills required and enhancing adherence.

Source:

Sahay, R., Gowda, A., Singh, M. K., Rao, A. G., Duraisamy, R., Gangwani, D., Shukla, J., Agarwal, V., Patil, S. S., C, A., K N, S. B., Palawat, A., Gofne, S. K., Sahoo, A. K., Rai, P. K., Shaikh, R., Saha, S., Patil, D., Ghadge, P., … Joglekar, S. (2026). 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. Diabetes, Obesity & Metabolism, 28(7), 6207–6216. https://doi.org/10.1111/dom.70778