What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

What question did this study set out to answer?

To assess the efficacy and safety of a triple fixed-dose combination of sitagliptin, metformin, and glimepiride.

May 6, 2026Diabetes Obesity and Metabolism0 citations

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

RSRakesh SahayOsmania General Hospital AGAmbanna GowdaPublic Citizen MSManish Kumar SinghRama Hospital & Research Centre

Key Points

To assess the efficacy and safety of a triple fixed-dose combination of sitagliptin, metformin, and glimepiride.
Conducted a randomised, double-blind, double-dummy Phase 3 clinical study.
Compared the efficacy of triple fixed-dose combination to co-administered metformin and high-dose glimepiride in Indian patients.
Followed participants from baseline to Week 16.
32.1% of the FDC group achieved glycaemic control below 7% at Week 16 compared to 12.6% in the Co-administration group (p < 0.0001).
Adverse events occurred in 13.2% of the FDC group and 14.9% in the Co-administration group.

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: from baseline to Week 16. RESULTS: 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 superior to co-administered metformin and high-dose glimepiride for achieving glycaemic control and was well tolerated in Indian patients with T2D. TRIAL REGISTRATION: Clinical Trials Registry-India identifier: CTRI/2021/11/038169 (registered on 22 November 2021); URL: https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NjI1Mjk=&Enc=&userName=.

Demander à l'IA

Bookmark

View Full Paper

Cite This Study

Sahay et al. (Sun,) studied this question.

synapsesocial.com/papers/69faa2b504f884e66b5334f2 https://doi.org/https://doi.org/10.1111/dom.70778

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

Demander à l'IA

Bookmark

View Full Paper