Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials
Authors' conclusion
The glucose-lowering efficacy of enavogliflozin is superior to that of dapagliflozin in patients with type 2 diabetes mellitus with mild renal function impairment; this is attributed to its potent urinary glucose excretion-promoting ability. The emergence of new and potent SGLT-2 inhibitors is considered an attractive option for patients with inadequate glycemic control and decreased renal function.
Study context
- Population
- Patients with T2D, classified by mildly reduced eGFR (60 ≤ eGFR < 90 mL/min/1.73 m², n = 247) or normal eGFR (≥ 90 mL/min/1.73 m², n = 223)2 RCTs pooled
- Participants
- 470 patients
- Comparison
- Enavogliflozin 0.3 mg/day vs dapagliflozin 10 mg/day as add-on therapy
- Enavogliflozinn = 235
- Dapagliflozinn = 235reference
- Outcome
- Adjusted mean change in HbA1c, mildly reduced eGFR subgroup
- Follow-up
- Week 24
Methodological details24-week, double-blind, phase III, subgroup analysis by renal function
- 24-week
- Double-blind
- Phase III
- Subgroup analysis by renal function
Pooled result
As reported in the abstract
Enavogliflozin
- 0.94
adjusted mean change · %
Dapagliflozin
−0.77
adjusted mean change · %
P = 0.0196
Further pooled results
Glucose-lowering efficacy by renal function
- Enavogliflozin showed potent glucose-lowering effects regardless of renal function
- Dapagliflozin glucose-lowering efficacy decreased significantly as renal function decreased
- Enavogliflozin HbA1c lowering more pronounced with DPP-4i than without
Urinary glucose excretion, insulin resistance, BP, weight, HOMA-beta
- Higher urinary glucose excretion rate with enavogliflozin in both eGFR groups
- Enavogliflozin markedly decreased insulin resistance (HOMA)
- BP, weight loss and HOMA beta-cell function did not differ significantly between drugs
Safety
- Adverse events were similar between both drugs
Original publication
Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials. Cardiovasc Diabetol. Published 15 February 2024. doi:10.
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