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 - 12/07/23
for the
ENHANCE-D Investigatorsa
Highlights |
• | Enavogliflozin showed 0.92% reduction of HbA1c as an add-on to metformin plus gemigliptin. |
• | Enavogliflozin showed non-inferior efficacy of HbA1c reduction compared to dapagliflozin. |
• | Enavogliflozin induced greater urinary glucose excretion than dapagliflozin. |
• | Enavogliflozin appeared to be safe and well-tolerated. |
Abstract |
Aims |
This study evaluated the efficacy and safety of enavogliflozin, a novel sodium-glucose cotransporter 2 inhibitor, versus dapagliflozin in Korean patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and gemigliptin.
Methods |
In this multicenter, double-blind, randomized study, patients with inadequate response to metformin (≥ 1000 mg/day) plus gemigliptin (50 mg/day) were randomized to receive enavogliflozin 0.3 mg/day (n = 134) or dapagliflozin 10 mg/day (n = 136) in addition to the metformin plus gemigliptin therapy. The primary endpoint was change in HbA1c from baseline to week 24.
Results |
Both treatments significantly reduced HbA1c at week 24 (–0.92% in enavogliflozin group, –0.86% in dapagliflozin group). The enavogliflozin and dapagliflozin groups did not differ in terms of changes in HbA1c (between-group difference: –0.06%, 95% confidence interval [CI]: –0.19, 0.06) and fasting plasma glucose (between-group difference: –3.49 mg/dl [–8.08;1.10]). An increase in urine glucose-creatinine ratio was significantly greater in the enavogliflozin group than in the dapagliflozin group (60.2 g/g versus 43.5 g/g, P < 0.0001). The incidence of treatment-emergent adverse events was similar between the groups (21.64% versus 23.53%).
Conclusions |
Enavogliflozin, added to metformin plus gemigliptin, was well tolerated and as effective as dapagliflozin in the treatment of patients with T2DM.
Le texte complet de cet article est disponible en PDF.Keywords : Enavogliflozin, HbA1c, Phase III study, Randomized controlled study, Sodium-glucose cotransporter 2 inhibitor, Type 2 diabetes mellitus
Plan
Vol 49 - N° 4
Article 101440- juillet 2023 Retour au numéro
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