CSPC Pharmaceutical Group Limited announced positive topline data from a multicentre, randomised, double-blind, parallel-controlled Phase III trial assessing a triple regimen of Prusogliptin Tablets combined with dapagliflozin and metformin hydrochloride extended-release in adult patients with type 2 diabetes mellitus (T2DM).
The study met its primary endpoint: after 24 weeks, the triple combination delivered a statistically significant greater reduction in glycated haemoglobin (HbA1c) from baseline compared with either of the two dual-therapy comparators—dapagliflozin + metformin or prusogliptin + metformin.
Safety outcomes were favourable. The overall incidence of adverse events for the triple therapy was comparable to that observed in both dual-therapy arms, indicating no additional safety risks.
Mechanistically, the regimen targets multiple T2DM pathways: prusogliptin (a DPP-4 inhibitor) enhances endogenous GLP-1 activity and insulin secretion; dapagliflozin (an SGLT2 inhibitor) promotes renal glucose excretion; and metformin improves peripheral glucose uptake, reduces hepatic glucose production, and enhances insulin sensitivity. The complementary actions are designed to intensify glycaemic control while maintaining a low hypoglycaemia risk, with potential ancillary benefits for blood pressure, body weight, pancreatic β-cell preservation and cardiorenal outcomes.
The announcement underscores CSPC Pharmaceutical’s continued progress in expanding its metabolic disease portfolio, with the Phase III success positioning prusogliptin for potential regulatory submission as part of a fixed-dose combination strategy targeting multifaceted management of T2DM.
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