|
KMID : 1200020230470060808
|
|
Diabetes & Metabolism Journal
2023 Volume.47 No. 6 p.808 ~ p.817
|
|
|
Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
|
|
Moon Jun-Sung
Park Il-Rae
Kim Hae-Jin
Chung Choon-Hee
Won Kyu-Chang
Han Kyung-Ah
Park Cheol-Young
Kim Dong-Jun
Koh Gwan-Pyo
Kim Eun-Sook
Yu Jae-Myung
Hong Eun-Gyoung
Lee Chang-Beom
Yoon Kun-Ho
|
|
|
Abstract
|
|
|
Background : This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods : In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results : Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, ?0.65% and ?0.55%; 95% confidence interval [CI], ?0.79 to ?0.51 and ?0.71 to ?0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion : Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
|
|
|
KEYWORD
|
|
|
Dapagliflozin, Diabetes mellitus, type 2, Dipeptidyl-peptidase IV inhibitors, Drug therapy, combination, Metformin
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|