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.

Autor: Moon JS; Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea., Park IR; Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea., Kim HJ; Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea., Chung CH; Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea., Won KC; Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea., Han KA; Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea., Park CY; Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea., Won JC; Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea., Kim DJ; Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea., Koh GP; Department of Internal Medicine, Jeju National University College of Medicine, Jeju, Korea., Kim ES; Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea., Yu JM; Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea., Hong EG; Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea., Lee CB; Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea., Yoon KH; Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Jazyk: angličtina
Zdroj: Diabetes & metabolism journal [Diabetes Metab J] 2023 Nov; Vol. 47 (6), pp. 808-817. Date of Electronic Publication: 2023 Sep 26.
DOI: 10.4093/dmj.2022.0387
Abstrakt: Backgruound: 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.
Databáze: MEDLINE
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