Efficacy and safety of DBPR108 (prusogliptin) as an add‐on to metformin therapy in patients with type 2 diabetes: A 24‐week, multi‐centre, randomized, double‐blind, placebo‐controlled, superiority, phase III clinical trial

AIM: To evaluate the efficacy and safety of DBPR108 (prusogliptin), a novel dipeptidyl peptidase‐4 (DPP‐4) inhibitor, as an add‐on therapy in patients with type 2 diabetes (T2D) that is inadequately controlled with metformin. MATERIALS AND METHODS: In this 24‐week, multi‐centre, randomized, double‐blind, placebo‐controlled, superiority, phase III study, adult T2D patients with HbA1c levels ranging from 7.0% to 9.5% on stable metformin were enrolled and randomized (2:1) into the DBPR108 + metformin and placebo + metformin groups. The primary endpoint was the change from baseline in HbA1c at week 24 of DBPR108 versus placebo as an add‐on therapy to metformin. RESULTS: At week 24, the least‐square mean (standard error) change from baseline in HbA1c was significantly greater in the DBPR108 group (−0.70% [0.09%]) than in the placebo group (−0.07% [0.11%]) (P < .001), with a treatment difference of −0.63% (95% confidence interval: −0.87%, −0.39%) on the full analysis set. A higher proportion of patients achieved an HbA1c of 6.5% or less (19.7% vs. 8.5%) and an HbA1c of 7.0% or less (50.0% vs. 21.1%) at week 24 in the DBPR108 + metformin group. Furthermore, add‐on DBPR108 produced greater reductions from baseline in fasting plasma glucose and 2‐hour postprandial plasma glucose without causing weight gain. The overall frequency of adverse events was similar between the two groups. CONCLUSIONS: DBPR108 as add‐on therapy to metformin offered a significant improvement in glycaemic control, was superior to metformin monotherapy (placebo) and was safe and well‐tolerated in patients with T2D that is inadequately controlled with metformin.