Efficacy and safety of saxagliptin monotherapy or added to metformin in Chinese patients with type 2 diabetes mellitus: results from the 24‐week, post‐marketing SUNSHINE study*†: 沙格列汀在中国2型糖尿病患者中单药治疗和与二甲双胍联合治疗24周的有效性和安全性分析:来自沙格列汀上市后的SUNSHINE研究结果. (6th March 2016) - Gu, Weiqiong
Abstract: Background: The aim of the present study was to explore the efficacy and safety of saxagliptin in a large Chinese population with type 2 diabetes mellitus (T2DM). Methods: In all, 1423 T2DM patients from 92 research centers, either drug naïve or uncontrolled by metformin, were enrolled in this single‐arm cohort study; patients were treated with saxagliptin 5 mg once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at 24 weeks in the per‐protocol analysis set. Secondary endpoints included the proportion of patients achieving HbA1c <7% and changes from baseline in fasting plasma glucose (FPG) and 2‐h postprandial plasma glucose (PPG) concentrations at 24 weeks. Safety endpoints included adverse events (AEs) and the incidence of hypoglycemia. Results: Among 1210 patients in the per‐protocol analysis set, mean HbA1c, FPG and 2‐h PPG decreased by 1.61 ± 0.04%, 0.55 ± 0.07 mmol/L, and 2.83 ± 0.27 mmol/L, respectively, at week 24. The proportion of patients achieving HbA1c <7% was 44.1%. No new (previously unreported) AEs occurred. The incidence of serious AEs and hypoglycemia was low (1.8% and 1.2%, respectively). There were no significant differences in efficacy endpoints in subgroup analyses by age, creatinine clearance, body mass index, or treatment background. In elderly patients (≥65 years) and those with mild renal impairment (50 < CCr ≤ 80 mL/min), the incidence of AEs was similar to that of the entire study population. Conclusions: Saxagliptin significantly improved glycemic control and was well tolerated in Chinese T2DM patients, including the elderly and patients with mild renal impairment. Abstract : (a) Mean (± SE) changes from baseline in HbA1c and the proportion of patients with HbA1c <7.0% over time in the per‐protocol analysis set (PPS; data as observed [DAO]; inset). (b) Mean changes from baseline in HbA1c at Week 24 in four subgroups of patients according to baseline HbA1c in the PPS (DAO).