CSPC Pharma (01093) has announced that the Phase III clinical trial of its developed Prucalopride Tablets in combination with Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets for the treatment of patients with type 2 diabetes mellitus (T2DM) has yielded positive topline analysis data.
Prucalopride is a dipeptidyl peptidase-IV (DPP-4) inhibitor that elevates endogenous active glucagon-like peptide-1 (GLP-1) levels by inhibiting DPP-4, increases insulin secretion in a glucose concentration-dependent manner, and suppresses glucagon secretion, thereby improving hyperglycemia. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2i) that inhibits renal glucose reabsorption and promotes urinary glucose excretion, thereby lowering blood glucose. Metformin increases peripheral tissue glucose uptake and utilization, reduces hepatic glucose production, inhibits intestinal glucose absorption, and improves insulin sensitivity. The combination of Prucalopride with Dapagliflozin and Metformin covers multiple pathological defects of T2DM through complementary mechanisms, enhancing glucose-lowering efficacy while maintaining a low risk of hypoglycemia, and offering multiple clinical advantages including blood pressure and weight reduction, protection of pancreatic beta cells, and cardiorenal benefits.
The trial was 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 Prucalopride, Dapagliflozin, and Metformin in treating T2DM. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline at 24 weeks of treatment. This pivotal study has met its prespecified primary endpoint and achieved positive topline results. Statistical analysis demonstrated that after 24 weeks of triple combination therapy with Prucalopride, Dapagliflozin, and Metformin, the reduction in HbA1c from baseline was significantly superior to that of the Dapagliflozin plus Metformin group or the Prucalopride plus Metformin group. In addition, the triple combination therapy demonstrated a favorable safety profile, with an overall incidence of adverse events comparable to the two dual combination therapies, without increasing safety risks.
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