The National Medical Products Administration (NMPA) in China has indicated on its website that CGeneTech (Suzhou, China) Co., Ltd.’s Category 1 drug, cetagliptin, has been granted marketing approval. This DPP-4 inhibitor is intended to improve blood sugar control in adult patients with type 2 diabetes (T2D).
Phase III Clinical Trial Outcomes
The Phase III clinical trial results demonstrated the efficacy of cetagliptin as a monotherapy in reducing hemoglobin A1c (HbA1c) levels. Specifically, the 50mg and 100mg dose groups experienced a reduction of 1.08% and 1.07%, respectively, by the end of the 24th week. When cetagliptin was combined with metformin, the glycated hemoglobin levels were reduced by 1.23% and 1.17% in the 50mg and 100mg dose groups, respectively, at the end of the 24th week.
Safety Profile of Cetagliptin
The incidence of adverse reactions associated with cetagliptin was found to be similar to that of the placebo group, indicating a good safety profile for the drug. This is a significant consideration for patients and healthcare providers when selecting treatment options for type 2 diabetes.-Fineline Info & Tech
