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

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=.