Key clinical point: Prusogliptin as an add-on therapy to metformin was superior to metformin monotherapy in improving glycemic control and was safe and well tolerated in patients with type 2 diabetes mellitus (T2D) inadequately controlled with metformin.
Major finding: At week 24, prusogliptin + metformin vs metformin + placebo led to significantly higher reductions in glycated hemoglobin (least squares mean change [LSM] −0.70% vs −0.07%; P < .001), fasting plasma glucose (LSM −0.63 vs 0.07 mmol/L; P = .025), and 2-hour postprandial plasma glucose (LSM −2.43 vs −0.70 mmol/L; P < .001) levels, with the incidence of adverse events being similar between the treatment groups.
Study details: Findings are from a 24-week, superiority, phase 3 trial including 206 patients with T2D with blood glucose levels inadequately controlled on metformin who were randomly assigned to receive prusogliptin + metformin (n = 138) or placebo + metformin (n = 68).
Disclosures: This study was funded by the CSPC Zhongqi Pharmaceutical Technology Co., Ltd. Some authors are employees of CSPC Zhongqi Pharmaceutical Technology.
Source: Xu J et al. Efficacy and safety of DBPR108 (prusogliptin) as an add-on to metformin therapy in patients with type 2 diabetes mellitus: A 24-week, multi-center, randomized, double-blind, placebo-controlled, superiority, phase III clinical trial. Diabetes Obes Metab. 2022 (Jul 6). Doi: 10.1111/dom.14810