Zhitong Financial App News, Shiyao Group (01093) announced that the pluglitin tablets (this product) developed by the Group recently obtained top-line analysis data in a phase III clinical trial of patients with type 2 diabetes (T2DM) in combination with pluglitine, dapagliflozin, and metformin.
Pluglitin is a dipeptidyl peptidase-IV (DPP-4) inhibitor. It increases endogenous active glucagon-like peptide-1 (GLP-1) levels by inhibiting DPP-4, increases insulin secretion in a glucose-dependent manner, and inhibits pancreatic glucagon secretion, thereby improving hyperglycemia. Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor (SGLT2i), which can inhibit renal reabsorption of glucose, promote urinary sugar excretion, and thereby lower blood sugar. By increasing the uptake and utilization of glucose by peripheral tissues, metformin reduces hepatic glucose production, inhibits intestinal absorption of glucose, and improves insulin sensitivity. Combined treatment with plugliptin, dagliflozin and metformin covers multiple pathological defects of T2DM through a complementary mechanism, enhances the efficacy of hypoglycemia while maintaining a low risk of hypoglycemia, and has multiple clinical advantages such as lowering blood pressure and body weight, protecting pancreatic beta cells, and bringing cardiac and renal benefits.
This trial is a multicenter, randomized, double-blind, parallel-controlled phase III clinical trial to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of a combination of pluglitin, dapagliflozin, and metformin in the treatment of T2DM. The primary endpoint was a change in glycated hemoglobin (HbA1c) compared to baseline at 24 weeks of treatment.
The key study has reached its intended primary endpoint and achieved positive top-line results. Statistical analysis showed that after 24 weeks of combined treatment with pluglitin, dapagliflozin, and metformin, the reduction in HbA1c in patients compared to the baseline was significantly superior to the treatment group of dagliflozin combined with metformin or pluagliptin combined with metformin. Furthermore, the three-drug combination treatment plan showed good safety. Compared with the above two-drug combination treatment plan, the overall incidence of adverse events was comparable, and there was no increase in safety risk.