Efficacy and Safety of Fixed-Dose Combination of Empagliflozin-Sitagliptin-Metformin ER versus Dapagliflozin-Sitagliptin-Metformin ER in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin: A Phase III Randomized Double-Blind Trial
Abstract
Abstract Objective: To evaluate the efficacy, safety, and tolerability of two fixed-dose combinations (FDCs) of empagliflozin, sitagliptin, and metformin extended release (ER) with dapagliflozin, sitagliptin, and metformin ER FDC in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin monotherapy. Materials and Methods: This was a multicenter ( n = 16), randomized, double-blind, active-controlled, phase III study (Clinical Trials Registry - India/2024/04/066077) conducted across India, between May 2024 and January 2025. The patients were randomized (1:1:1) to receive FDC of empagliflozin 10 mg/sitagliptin 100 mg/metformin 1000 mg ER (Arm A); empagliflozin 25 mg/sitagliptin 100 mg/metformin 1000 mg ER (Arm B); dapagliflozin 10 mg/sitagliptin 100 mg/metformin 1000 mg ER (Arm C). The primary endpoint was the mean change in glycated hemoglobin (HbA1c) at week 16. Secondary endpoints included changes in fasting plasma glucose (FPG) and postprandial glucose (PPG). Adverse events (AEs) were recorded as part of the safety assessment. Results: A total of 315 patients were included in the study: Arm A ( n = 104), Arm B ( n = 106), and Arm C ( n = 105). At week 16, Arm B (−1.77%) demonstrated a significant reduction in HbA1c compared to Arm A (−1.54%) and Arm C (−1.53%). Arm B (−49.51 mg/dL) also showed a significant reduction in FPG compared to Arms A and C. Changes in PPG, body weight, systolic blood pressure, and glycemic target attainment were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 315 participants or records.
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