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

• Published in: Diabetes & metabolism journal 2023, 47(6), 200, pp.808-817
• Main Authors: Moon, Jun Sung, Park, Il Rae, Kim, Hae Jin, Chung, Choon Hee, Won, Kyu Chang, Han, Kyung Ah, Park, Cheol-Young, Won, Jong Chul, Kim, Dong Jun, Koh, Gwan Pyo, Kim, Eun Sook, Yu, Jae Myung, Hong, Eun-Gyoung, Lee, Chang Beom, Yoon, Kun-Ho
• Format: Article
• Language: English
• Subjects: dapagliflozin; diabetes mellitus, type 2; Diabetes Mellitus, Type 2 - chemically induced; Diabetes Mellitus, Type 2 - drug therapy; dipeptidyl-peptidase iv inhibitors; Drug Therapy, Combination; Glucose; Glycated Hemoglobin; Humans; Hypoglycemic Agents - adverse effects; metformin; Metformin - adverse effects; Original; 내과학
• ISSN: 2233-6079; 2233-6087
• DOI: 10.4093/dmj.2022.0387

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. 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). 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