Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on Metformin Monotherapy: A Multicentric Randomized Trial

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2024年12月5日

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Awadhesh Kumar Singh,
Ashok Kumar Das,
L. Sreenivasa Murthy,
Samit Ghosal,
Rakesh Sahay,
K. V. S. Harikumar,
Ganesh Hosahithlu Keshava,
Mayur Agarwal,
G. Vijayakumar,
Pramila Kalra,
Piyush Lodha,
Sambit Das,
Shehla Shaikh,
Soumik Goswami,
T. P. Ajish,
Prashant Kumthekar,
Mihir Upadhyay,
Anthuvan Thamburaj,
Aushili Mahule,
Ashish Prasad,
Abhijit Pednekar

摘要

Introduction

A slower adoption rate of fixed dose combinations (FDC) in diabetes management is partly due to insufficient data. This study evaluates the safety and efficacy of an FDC of dapagliflozin + sitagliptin + metformin hydrochloride extended release (XR), compared to a dual FDC of sitagliptin + metformin hydrochloride XR among patients with type 2 diabetes mellitus (T2DM) with poor glycemic control when treated with metformin monotherapy.

Methods

A total of 274 patients with T2DM were randomized (1:1) to either arm X, receiving FDC of dapagliflozin (10 mg) + sitagliptin (100 mg) + metformin hydrochloride XR (1000 mg) (Dapa + Sita + Met) tablets, or arm Y, receiving sitagliptin phosphate (100 mg) + metformin hydrochloride XR (1000 mg) (Sita + Met) tablets, and treated for 16 weeks. The outcome measures included changes in hemoglobin A1c (HbA1c)(%), fasting plasma glucose (FPG), 2-h post-prandial glucose (PPG), weight, and the proportion of patients achieving target HbA1c levels of < 7.0% by week 16 of the study period.

Results

The reduction in HbA1c at week 16 was significantly higher in arm X than in arm Y [estimated treatment difference (ETD), − 0.65% (95% CI − 0.76 to − 0.53; P < 0.0001)]. Arm X showed a marked decrease in FPG [ETD − 15.42 mg/dl; 95% CI (17.63, 13.22; P < 0.0001)], PPG [ETD − 30.39 mg/dl; 95% CI (35.59, 25.19; P < 0.0001)], and weight [ETD − 1.47 kg; 95% CI (1.59, 1.28; P < 0.0001)] after 16 weeks. In arm X, 54% of patients reached HbA1c < 7.0% compared to 29.9% in arm Y. The incidence of adverse events was comparable [13.14% (arm X) vs 12.4% (arm Y)]. There was no severe hypoglycemia-led treatment discontinuation.

Conclusion

Among patients with T2DM who have poor glycemic control with metformin monotherapy, triple FDC (Dapa + Sita + Met) effectively helped achieve better glycemic response compared to dual FDC (Sita + Met), with a comparable safety and tolerability profile.

Trial Registration

CTRI/2022/01/039857