Fixed dose combination of dapagliflozin, glimepiride and extended‐release metformin tablets in patients with type 2 diabetes poorly controlled by metformin and glimepiride: A phase III , open label, randomized clinical study in India
Authors' conclusion
This study demonstrated that the FDC of DAPA + GLIM + MET ER tablets once daily was significantly better than dual FDC in achieving glycaemic control in patients with poorly controlled T2DM. Both treatments were well-tolerated.
Study context
- Population
- Indian patients with T2D inadequately controlled by GLIM + METrandomized 1:1
- Comparison
- Fixed-dose combination (FDC) of DAPA + GLIM + MET ER vs FDC of GLIM + MET prolonged-release (PR), once daily
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 16
Methodological detailsphase III, open-label, active-controlled, Maximum 30 weeks: primary treatment 16 weeks, uptitration 12 weeks, follow-up 2 weeks
- Phase III
- Open-label
- Active-controlled
- Maximum 30 weeks: primary treatment 16 weeks, uptitration 12 weeks, follow-up 2 weeks
Primary result
As reported in the abstract
Mean reduction in HbA1c from baseline
DAPA + GLIM + MET ER
−1.98
mean · ± 1.01 · %
GLIM + MET PR
−1.64
mean · ± 0.86 · %
P = 0.0047
Further findings
Patients achieving HbA1c <7.0% · week 12
P = 0.0002
Patients achieving HbA1c <7.0% · week 16
P = 0.0015
- Mean reduction in HbA1c from baseline · week 12 · significantly greater reduction with DAPA + GLIM + MET ER
- P < 0.0001
HbA1c, fasting and post-prandial blood glucose within groups · weeks 12, 16 and 28
- Significant decrease from baseline in both arms
Safety
- Incidence of TEAEs similar across both arms
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Fixed dose combination of dapagliflozin, glimepiride and extended‐release metformin tablets in patients with type 2 diabetes poorly controlled by metformin and glimepiride: A phase III , open label, randomized clinical study in India. Diabetes Obes Metab. Published 14 February 2025. doi:10.
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