Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes
Abstract
AIM: To compare the efficacy and safety of monotherapy with sitagliptin and metformin in treatment-naïve patients with type 2 diabetes.
METHODS: In a double-blind study, 1050 treatment-naïve patients (i.e. not taking an antihyperglycaemic agent for > or =16 weeks prior to study entry) with type 2 diabetes and an HbA(1c) 6.5-9% were randomized (1:1) to treatment with once-daily sitagliptin 100 mg (N = 528) or twice-daily metformin 1000 mg (N = 522) for 24 weeks. Metformin was up-titrated from 500 to 2000 mg per day (or maximum tolerated daily dose > or =1000 mg) over a period of 5 weeks. The primary analysis used a per-protocol (PP) approach to assess whether sitagliptin was non-inferior to metformin based on HbA(1c) change from baseline at week 24. Non-inferiority was to be declared if the upper boundary of the 95% confidence interval (CI) for the between-group difference in this endpoint was <0.40%.
RESULTS: From a mean baseline HbA(1c) of 7.2% in the PP population, HbA(1c) change from baseline was -0.43% with sitagliptin (n = 455) and -0.57% with metformin (n = 439). The between-group difference (95% CI) was 0.14% (0.06, 0.21), thus confirming non-inferiority. Baseline HbA(1c) influenced treatment response, with larger reductions in HbA(1c) observed in patients with baseline HbA(1c)> or =8% in the sitagliptin (-1.13%; n = 74) and metformin (-1.24%; n = 73) groups. The proportions of patients at week 24 with HbA(1c) values at the goals of <7 or <6.5% were 69 and 34% with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 528 participants or records.
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