Long‐term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52‐week extension of a Phase 3 randomized controlled trial
Authors' conclusion
Enavogliflozin 0.3 mg monotherapy provides long-term glycaemic control in T2DM and is safe and well tolerated during a 52-week treatment period.
Study context
- Population
- Individuals with T2D on enavogliflozin monotherapy
- Participants
- 37 vs 26
- Comparison
- Continued enavogliflozin vs switch from placebo to enavogliflozin
- Maintenancen = 37
- Switchn = 26
- Primary endpoint
- Long-term safety and efficacy of enavogliflozin
- Follow-up
- Week 52
Methodological details24-week randomized, double-blind treatment period, 28-week open-label extension, placebo-controlled
- 24-week randomized, double-blind treatment period
- 28-week open-label extension
- Placebo-controlled
Primary result
As reported in the abstract
HbA1c change from baseline
Maintenance
0.9%
Switch
0.7%
- HbA1c significantly lower than baseline, maintenance (p < 0.0001)
- 0.9%
- HbA1c significantly lower than baseline, switch (p < 0.0001)
- 0.7%
Further findings
Reaching HbA1c 7.0% (53 mmol/mol) · Week 52
Urine glucose-to-creatinine ratio increase from baseline · Week 52
Body weight decrease from baseline · Week 52
mg/dL
| Outcome | Maintenance | Switch |
|---|---|---|
| FPG change from baseline (decrease) · Week 52 | 24.9 | 18.0 |
- FPG change from baseline (decrease) — Maintenance vs baseline
- p < 0.0001
- FPG change from baseline (decrease) — Switch vs baseline
- p = 0.002
- Urine glucose-to-creatinine ratio increase from baseline — Significant increase in both groups
- p < 0.0001 for both
- Body weight decrease from baseline — Significant decrease in both groups
- p < 0.0001
Safety
- No additional adverse drug reactions related to enavogliflozin during the open-label extension (OLE) period
Original publication
Long‐term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52‐week extension of a Phase 3 randomized controlled trial. Diabetes Obes Metab. Published 26 July 2024. doi:10.
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