CSPC PHARMA (01093): Positive topline results from Phase III clinical trial of Prusogliptin Tablets combined with Dapagliflozin Tablets and Metformin Hydrochloride Extended-Release Tablets for the treatment of type 2 diabetes

CSPC PHARMA (01093) announced that the Phase III clinical trial of Prusogliptin Tablets (the Product), developed by the Group, in combination with Dapagliflozin and Metformin for the treatment of patients with type 2 diabetes mellitus (T2DM) has recently obtained topline analysis data. Prusogliptin is a dipeptidyl peptidase-IV (DPP-4) inhibitor that inhibits DPP-4 to increase the level of endogenous active glucagon-like peptide-1 (GLP-1), and increases insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent manner, thereby improving hyperglycemia. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2i) that inhibits renal reabsorption of glucose, promotes urinary glucose excretion, and thereby lowers blood glucose. Metformin increases peripheral tissue uptake and utilization of glucose, reduces hepatic glucose production, inhibits intestinal absorption of glucose, and improves insulin sensitivity. The combination of Prusogliptin with Dapagliflozin and Metformin covers multiple pathological defects of T2DM through complementary mechanisms, enhancing glycemic efficacy while maintaining a low risk of hypoglycemia, and offering multiple clinical advantages including blood pressure and weight reduction, protection of pancreatic -cells, and cardiovascular and renal benefits. The trial is a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of the triple combination of Prusogliptin, Dapagliflozin, and Metformin in the treatment of T2DM. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline at 24 weeks of treatment. This pivotal study has reached the prespecified primary endpoint and achieved positive topline results. Statistical analysis demonstrated that after 24 weeks of treatment with the triple combination of Prusogliptin, Dapagliflozin, and Metformin, the reduction in HbA1c from baseline was significantly superior to that of the Dapagliflozin plus Metformin group or the Prusogliptin plus Metformin group. In addition, the triple combination regimen demonstrated a favorable safety profile, with an overall incidence of adverse events comparable to that of the above two dual combination regimens, without increasing safety risks.