Efficacy and safety of enavogliflozin versus dapagliflozin added to metformin plus gemigliptin treatment in patients with type 2 diabetes: A double-blind, randomized, comparator-active study: ENHANCE-D study
Primary result · Change in HbA1cResult — go to the resultBetween-group difference −0.06 % 95% CI −0.19 to 0.06Authors' conclusion
Enavogliflozin, added to metformin plus gemigliptin, was well tolerated and as effective as dapagliflozin in the treatment of patients with T2DM.
Study context
- Population
- Korean patients with T2D inadequately controlled with metformin (≥ 1000 mg/day) plus gemigliptin (50 mg/day)
- Participants
- 134 vs 136
- Comparison
- Enavogliflozin 0.3 mg/day vs dapagliflozin 10 mg/day, added to metformin plus gemigliptin
- Enavogliflozinn = 134
- Dapagliflozinn = 136reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsmulticentre, double-blind, active comparator
- Multicentre
- Double-blind
- Active comparator
Primary result
Change in HbA1c
Between-group difference
−0.06 %
95% CI −0.19 to 0.06
Change by group
Enavogliflozin
−0.92
%
Dapagliflozin
−0.86
%
Enavogliflozinvs Dapagliflozin
between-group difference −0.06 % (95% CI −0.19 to 0.06)
As reported in the abstract
Further findings
| Outcome | Between-group difference (mg/dl) (CI) | |
|---|---|---|
| FPGGroups did not differ | −3.49 (−8.08 to 1.10) | |
| −10−505Difference, mg/dl (linear scale) |
Increase in urine glucose-creatinine ratio · significantly greater with enavogliflozin
P < 0.0001
Safety
Treatment-emergent adverse events
Treatment-emergent adverse events
- Incidence similar between the groups
Original publication
Efficacy and safety of enavogliflozin versus dapagliflozin added to metformin plus gemigliptin treatment in patients with type 2 diabetes: A double-blind, randomized, comparator-active study: ENHANCE-D study. Diabetes Metab. Published 9 March 2023. doi:10. 1016/ j. diabet. 2023. 101440
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