Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial
Primary result · Change in HbA1c from baselineResult — go to the resultPlacebo-adjusted mean change −0.99 % 95% CI −1.24% to −0.74%Authors' conclusion
Monotherapy with enavogliflozin 0.3 mg improved glycaemic control in people with T2DM. Enavogliflozin therapy also exerted beneficial effects on body weight, blood pressure and lipid profile.
Study context
- Population
- Korean people with T2D inadequately controlled with diet and exercise (haemoglobin A1c (HbA1c) 7.0%-10.0% after ≥8 weeks of diet and exercise modification), 23 hospitals
- Participants
- 83 vs 84
- Comparison
- Enavogliflozin 0.3 mg monotherapy vs placebo
- Enavogliflozinn = 83
- Placebon = 84reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, phase III, multicentre (23 hospitals)
- Double-blind
- Placebo-controlled
- Phase III
- Multicentre (23 hospitals)
Primary result
As reported in the abstract
Placebo-adjusted mean change
−0.99 %
95% CI −1.24% to −0.74%
Enavogliflozinvs Placebo
placebo-adjusted mean change −0.99 % (95% CI −1.24% to −0.74%)
Secondary outcomes
HbA1c <7.0% · week 24 · significantly higher with Enavogliflozin
P < 0.0001
| Outcome | Estimate | P value |
|---|---|---|
| Change in fasting plasma glucose · week 24 | placebo-adjusted mean change −40.1 mg/dl | P < 0.0001 |
| Change in body weight · week 24 | placebo-adjusted mean change −2.5 kg | P < 0.0001 |
Blood pressure, lipids and HOMA-IR
- Significant decrease in blood pressure, LDL-C, TG and HOMA-IR, and significant increase in HDL-C
Safety
- No significant increase in treatment-related adverse events with enavogliflozin
Original publication
Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial. Diabetes Obes Metab. Published 23 March 2023. doi:10.
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