Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study
Authors' conclusion
Dapagliflozin add-on to evogliptin plus metformin improved glycaemic control and was well tolerated by the target patients.
Study context
- Population
- Patients with T2D with HbA1c ≥7.0% and ≤10.5% on stable-dose metformin (≥1000 mg) and evogliptin (5 mg) for at least 8 weeks195 in efficacy analyses
- Participants
- 198 patients
- Comparison
- Dapagliflozin 10 mg vs placebo once daily as add-on to evogliptin plus metformin
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- 24 weeks
Methodological detailsmulticentre, double-blind, placebo-controlled, phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 3
Primary result
As reported in the abstract
- At week 24, dapagliflozin significantly reduced HbA1c levels
- 195 included in efficacy analyses
Further findings
HbA1c <7.0% achieved
- Proportion achieving HbA1c <7.0% higher with dapagliflozin than placebo
Other metabolic outcomes
- Dapagliflozin vs placebo significantly reduced FPG, mean daily glucose, 2-h postprandial glucose, fasting insulin, uric acid, gamma-glutamyl transferase, HOMA-IR, body weight, hepatic steatosis index and albuminuria
- Adiponectin significantly increased from baseline after 24 weeks of dapagliflozin
Safety
- Adverse event rates were similar in the two groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study. Diabetes Obes Metab. Published 2 September 2024. doi:10.
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