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

• Published in: Diabetes, obesity & metabolism Vol. 24; no. 11; pp. 2232 - 2240
• Main Authors: Xu, Jianping, Ling, Hongwei, Geng, Jianlin, Huang, Yanli, Xie, Ying, Zheng, Huiping, Niu, Huikun, Zhang, Tianhao, Yuan, Jing, Xiao, Xinhua
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.11.2022; Wiley Subscription Services, Inc
• Subjects: Adult; Antidiabetics; Blood Glucose; Butanes; Clinical trials; DBPR108; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors - adverse effects; Dipeptidyl-Peptidases and Tripeptidyl-Peptidases - therapeutic use; Double-Blind Method; Double-blind studies; DPP‐4 inhibitor; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemic Agents - adverse effects; Metformin; Metformin - adverse effects; Nitriles; Original; Patients; Peptidase; Placebos; Pyrrolidines; Treatment Outcome; type 2 diabetes; metformin; type 2 diabetes; DBPR108; DPP-4 inhibitor
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14810

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.