Fotagliptin add‐on therapy to metformin in patients with uncontrolled type 2 diabetes: A randomised, multicentre, double‐blind, placebo‐controlled, phase 3 trial

• DOI: 10.1111/dom.16427
• Publication Date: 2025-04-30T08:20:34Z
• Authors: Nan Yu; Wenjie Xu; Xiaohui Guo; Mingtong Xu; Wei Zhang; Chaoli Yan; Shuguang Pang; Xiuhai Shu; Wei Zhang; Weixia Peng; Yawei Zhang; Gaixian Li; Xin Zhang; Dongmei Zhou
• Keywords: Clinical endpoint; Dipeptidyl peptidase-4 inhibitor

Abstract Aim Fotagliptin is a novel dipeptidyl peptidase‐4 inhibitor for glycaemic control in patients with type 2 diabetes (T2D). This trial aimed to assess the efficacy and safety of fotagliptin add‐on metformin T2D. Materials Methods In this phase 3 randomised, double‐blind, placebo‐controlled study, T2D who had inadequate using alone were randomly allocated or placebo at 2:1 ratio 24‐week double‐blind treatment period, followed by an open‐label all patients, making up total 52 weeks. All eligible treated stable dose (≥1500 mg per day). The primary endpoint was change HbA1c level from baseline week 24. Safety assessed received least one study drug. Results After 24 weeks, LS mean −0.81% versus −0.28% placebo. Estimated difference −0.53% (95% confidence interval [CI] −0.68% −0.39%; p < 0.001). Significantly more on than achieved 7.0% after weeks (38.7% vs. 16.9%; incidence adverse events similar between two groups. No severe hypoglycaemia reported combined therapy. Conclusions experienced metformin, superior clinically meaningful improvement compared