Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial

AimTo assess the efficacy and safety of saxagliptin plus metformin over 24weeks in pharmacotherapy-naive Chinese patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c, 8.0%-12.0%). Research Design and MethodsIn this multicentre, double-blind, active-controlled study (The START study: NCT02273050, ), patients were randomized (1:1:1) to saxagliptin 5mg plus metformin, saxagliptin 5mg plus placebo or metformin plus placebo. Saxagliptin was taken once daily; metformin was taken once/twice daily and was titrated from 500mg to a maximum of 2000mg/d over 8weeks. The primary end point was change in HbA1c from baseline to Week 24. ResultsData from 630 patients (66.5% men; mean age, 50.1years; mean body mass index, 26.6kg/m(2); mean HbA1c, 9.4%; mean diabetes duration, 0.81years) were analysed. Mean reduction in HbA1c was greater with saxagliptin plus metformin (-3.0%) than with saxagliptin plus placebo (-2.1%; P<.001) or metformin plus placebo (-2.8%; P=.034). Changes in mean fasting plasma glucose, 120-minute postprandial glucose, and 180-minute postprandial glucose area under the curve were greater, and more patients achieved a therapeutic glycaemic response, with saxagliptin plus metformin than with either monotherapy. Hypoglycaemic events were infrequent (<2%). Incidence of adverse events was similar among groups; upper respiratory tract infection and diarrhoea were most common. ConclusionsSaxagliptin 5mg plus metformin significantly improved glycaemic control compared with either monotherapy in treatment-naive Chinese patients with type 2 diabetes, and was well tolerated.