PMID- 26676908 OWN - NLM STAT- MEDLINE DCOM- 20180130 LR - 20221207 IS - 1753-0407 (Electronic) IS - 1753-0407 (Linking) VI - 8 IP - 6 DP - 2016 Nov TI - 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. PG - 809-815 LID - 10.1111/1753-0407.12360 [doi] AB - 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 naive 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