Efficacy and safety of monotherapy with enavogliflozin in Korean patients with type 2 diabetes mellitus: Results of a 12‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase 2 trial
Authors' conclusion
Once-daily enavogliflozin monotherapy for 12 weeks is an effective, safe, and well-tolerated treatment for Korean patients with type 2 diabetes mellitus.
Study context
- Population
- Korean patients with T2D and HbA1c 7.0–10.0%full analysis set
- Participants
- 194 patients
- Comparison
- Once-daily enavogliflozin vs placebo for 12 weeks
- Enavogliflozin 0.1 mgn = 49
- Enavogliflozin 0.3 mgn = 50
- Enavogliflozin 0.5 mgn = 49
- Placebon = 46reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 12
Methodological detailsmulticentre, double-blind, placebo-controlled, phase 2, 2-week placebo run-in
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 2
- 2-week placebo run-in
Primary result
As reported in the abstract
Enavogliflozin 0.1 mg
−0.79
%
Enavogliflozin 0.3 mg
−0.89
%
Enavogliflozin 0.5 mg
−0.92
%
Placebo
−0.08
%
Enavogliflozin 0.1 mg vs Placebo: P < 0.001 vs. placebo · Enavogliflozin 0.3 mg vs Placebo: P < 0.001 vs. placebo · Enavogliflozin 0.5 mg vs Placebo: P < 0.001 vs. placebo
Further findings
HbA1c <7.0% · week 12
HbA1c reduction >0.5%
Mean, mg/dl
| Outcome | Enavogliflozin 0.1 mg | Enavogliflozin 0.3 mg | Enavogliflozin 0.5 mg | Placebo |
|---|---|---|---|---|
| Mean change in FPG from baseline · week 12 | −30.5 | −31.1 | −35.0 | 4.9 |
HbA1c <7.0% · week 12
- Significantly higher in the three enavogliflozin groups than placebo
Safety
AEs of hypoglycaemia and genital infection
- No significant differences in incidences between the groups
Original publication
Efficacy and safety of monotherapy with enavogliflozin in Korean patients with type 2 diabetes mellitus: Results of a 12‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase 2 trial. Diabetes Obes Metab. Published 24 April 2023. doi:10.
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