Diabetes Daily Report: 01/15/2024

A phase 3 randomized, double-blind, active and placebo-controlled study investigated the effect of prusogliptin (DBPR108) in 766 patients with newly diagnosed type 2 diabetes who had not used glucose-lowering agents for at least 8 weeks prior to the study (1). The study compared DBPR108 100 mg, sitagliptin 100 mg, and placebo, administered once daily. The primary outcome was the mean change in glycated haemoglobin (HbA1c) levels from baseline to week 24. The results showed that at week 24, the least square mean changes from baseline in HbA1c were -0.63% for DBPR108, -0.60% for sitagliptin, and -0.02% for placebo. The treatment difference between DBPR108 and placebo was -0.61% (95% CI -0.77% to -0.44%), and between DBPR108 and sitagliptin was -0.03% (95% CI -0.19% to 0.13%), indicating DBPR108's superiority to placebo and non-inferiority to sitagliptin. DBPR108 also significantly reduced fasting and postprandial plasma glucose levels and had minimal impact on body weight. At week 52, the mean changes in HbA1c were -0.50% for DBPR108, -0.46% for sitagliptin, and -0.41% for placebo. The incidence of adverse events was similar across all groups, suggesting DBPR108 is effective and safe for glycaemic control over 52 weeks in treatment-naïve patients with type 2 diabetes.

Reference

Wang W, Guo X, Zhang C, Ning T, Ma G, Huang Y, Jia R, Zhou D, Cao M, Zhang T, Yao L, Yuan J, Chen L; DBPR108 monotherapy phase 3 study collaborative group. Prusogliptin (DBPR108) monotherapy in treatment-naïve patients with type 2 diabetes: A randomized, double-blind, active and placebo-controlled, phase 3 study. Diabetes Obes Metab. 2024 Jan 15. doi: 10.1111/dom.15433. Epub ahead of print. PMID: 38221859.