Efficacy and safety of cofrogliptin once every 2weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2025-01, Vol.27 (1), p.280-290
• Main Authors: Gao, Leili, Bian, Fang, Pan, Tianrong, Jiang, Hongwei, Feng, Bo, Jiang, Chengxia, Sun, Jia, Xiao, Jianzhong, Pangke Yan, Ji, Linong
• Format: Article
• Language: English
• Subjects: Clinical trials; Diabetes; Diabetes mellitus (non-insulin dependent); Hemoglobin; Hyperlipidemia; Hyperuricemia; Placebos; Respiration; Respiratory tract infection; Urinary tract
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.16014

AimWe conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long‐acting dipeptidyl peptidase‐4 inhibitor, in patients with drug‐naïve type 2 diabetes (T2D).Materials and MethodsPatients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24‐week double‐blind period. Eligible patients then received cofrogliptin 25 mg in a 28‐week open‐label extension. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24.ResultsIn total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open‐label extension. At week 24, the least‐squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was −0.63% (−0.81, −0.46) with cofrogliptin 10 mg and −0.59% (−0.77, −0.42) with cofrogliptin 25 mg (both p