Diabetes, obesity & metabolism · 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.
Рандомизированное исследованиеСтатьяКлиническое исследование III фазыСравнительное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Sahay Rakesh, Gowda Ambanna, Singh Manish Kumar, Rao A Gopal, Duraisamy Ramesh, Gangwani Dinesh, Shukla Jitendra, Agarwal Vikas, Patil Sandesh Sahebarao, C Ambrish, K N Satish Babu, Palawat Arvind, Gofne Sandip Krishnrao, Sahoo Abhay Kumar, Rai Pradeep Kumar, Shaikh Raisa, Saha Shruti, Patil Dipak, Ghadge Pravin, Patel Piyush, Lakhwani Lalit, Mehta Suyog, Joglekar Sadhna
Аннотация
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 < 0.0001). The proportion of patients with HbA1c 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=.
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 < 0.0001). The proportion of patients with HbA1c 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=.