A Randomized, Multicenter Study Evaluating the Efficacy, Safety and Tolerability of Dapagliflozin + Gliclazide Fixed Dose Combination Over Dapagliflozin Monotherapy in Type 2 Diabetes Mellitus Patient
6 hours ago
- #Type 2 Diabetes Mellitus
- #Glycemic Control
- #Fixed Dose Combination
- Study compared efficacy and safety of dapagliflozin + gliclazide SR FDC vs. dapagliflozin monotherapy in T2DM patients poorly controlled on metformin.
- 244 patients randomized 1:1 to receive either FDC or dapagliflozin monotherapy for 16 weeks.
- Primary endpoint: adjusted mean change in HbA1c from baseline to week 16.
- FDC showed statistically significant greater HbA1c reduction (8.76% to 6.97%) vs. monotherapy (8.80% to 7.32%).
- FDC was well-tolerated with a favorable safety profile.
- Conclusion: FDC of dapagliflozin + gliclazide SR is more efficacious than dapagliflozin alone in this patient population.