The Efficacy of Cofrogliptin for Glycemic Control in Relapsed Type 2 Diabetes: A 12-Week Single-Center, Single-Arm, Exploratory Study

Introduction and Objective: Relapse of type 2 diabetes (T2D) following a period of glycemic remission (HbA1c<6.5% without glucose-lowering medications for ≥3 months), is increasingly recognized. The management of this patient population necessitates re-initiation of pharmacotherapy, placing a premium on therapeutic agents that offer convenience, favorable long-term safety, and the potential to support sustained treatment adherence. Cofrogliptin is a novel DPP-4 inhibitor (DPP-4i) characterized by biweekly administration, offering potential clinical advantages such as low hypoglycemic risk, independence from renal dose adjustment, and a minimal interaction profile. However, data on the efficacy and safety of cofrogliptin in this specific population remain unexplored. This study aims to assess, for the first time, the 12-week efficacy and safety of cofrogliptin in this specific patient group. Methods: In this single-center, single-arm, exploratory trial, patients with relapsed T2D (post-remission HbA1c≥6.5%) were treated with biweekly oral cofrogliptin (10 mg) for 12 weeks. The primary endpoint was the proportion of patients achieving HbA1c targets of <6.5% and <7.0% at Week 12. Results: A total of 20 participants were enrolled (median age 37.5 years) with a mean baseline HbA1c of 6.91%. A 12-week treatment of cofrogliptin resulted in 40% achieving an HbA1c<6.5% compared to none at baseline (p<0.001), and 60% achieved <7.0% versus 30% initially (p<0.001). The regimen was well tolerated, with no severe hypoglycemic events reported. Conclusion: In patients with T2D following glycemic remission relapse, 12-week treatment with cofrogliptin significantly improved HbA1c target achievement rates. These findings position it as a viable therapeutic option for this specific clinical scenario. Disclosure: S. Shao: None. Q. Yu: None. Z. Zhao: None.