Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial

作者：Mauricio N. Jadzinsky, Andreas Pfützner, Elizabeth T. Paz-Pacheco, Zherong Xu, Elsie Allen, R. Chen, CV181‐039 Investigators · 发表于：Diabetes Obesity and Metabolism · 年份：2009 · DOI：10.1111/j.1463-1326.2009.01056.x · 被引用次数：295 · 研究领域：Diabetes Treatment and Management、Diabetes, Cardiovascular Risks, and Lipoproteins、Metabolism, Diabetes, and Cancer

AIM: The study aim was to evaluate the efficacy and safety of initial combination therapy with saxagliptin + metformin vs. saxagliptin or metformin monotherapy in treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycaemic control. METHODS: In this multicentre, randomized, double-blind, active-controlled phase 3 trial, 1306 treatment-naïve patients with T2D >or=18 to or=8 to or=1.0 ng/ml, body mass index <or=40 kg/m(2) were randomized to receive saxagliptin 5 mg + metformin 500 mg, saxagliptin 10 mg + metformin 500 mg, saxagliptin 10 mg + placebo or metformin 500 mg + placebo for 24 weeks. From weeks 1-5, metformin was uptitrated in 500-mg/day increments to 2000 mg/day maximum in the saxagliptin 5 mg + metformin, saxagliptin 10 mg + metformin and metformin + placebo treatment groups. The main outcome measure was HbA1c change from baseline to week 24. Selected secondary outcomes included change from baseline to week 24 in fasting plasma glucose (FPG), proportion of patients achieving HbA1c <7% and postprandial glucose area under the curve (PPG-AUC). RESULTS: At 24 weeks, saxagliptin 5 mg + metformin and saxagliptin 10 mg + metformin demonstrated statistically significant adjusted mean decreases vs. saxagliptin 10 mg and metformin monotherapies in HbA1c (-2.5 and -2.5% vs. -1.7 and -2.0%, all p < 0.0001 vs. monotherapy) and FPG (-60 and -62 mg/dl vs. -31 and -47 mg/dl, both p < 0.0001 vs. saxagliptin 10 mg; p = 0.0002 saxagliptin 5 mg + metformin vs. metformin;...