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Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal‐F1)

2013; Wiley; Volume: 31; Issue: 2 Linguagem: Inglês

10.1111/dme.12328

1464-5491

Geremia B. Bolli, Mihnea Munteanu, S. Ya. Dotsenko, Elisabeth Niemoeller, G. Boka, Yongjin Wu, M Hanefeld,

Diabetes Management and Research

Abstract Aims To assess the efficacy and safety of one‐ and two‐step dose‐increase regimens of lixisenatide once daily in participants with Type 2 diabetes mellitus insufficiently controlled with metformin. Methods This was a randomized, double‐blind, placebo‐controlled, parallel‐group, multi‐centre study enrolling participants with Type 2 diabetes ( n = 484) treated with metformin. Participants were randomized to receive either lixisenatide in a one‐step dose increase or a two‐step dose increase vs. placebo for 24 weeks, followed by a ≥ 52‐week variable double blind period. Primary outcome was HbA 1c reduction at week 24. Results Lixisenatide one‐/two‐step once daily significantly improved HbA 1c at week 24 compared with placebo ( P < 0.0001) and allowed more participants to achieve HbA 1c < 53 mmol/mol (< 7.0%) ( P ≤ 0.0005). Improvements were observed in fasting plasma glucose (–0.5/–0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (–2.6/–2.7 vs. –1.6 kg; P < 0.005). At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one‐/two‐step/placebo, respectively—nausea and vomiting being reported most frequently. Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one‐/two‐step lixisenatide and 0.6% with placebo, with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable double‐blind extension period of at least 52 weeks. Conclusions Lixisenatide one‐ or two‐step dose‐increase regimens significantly improved glycaemic control and decreased body weight over 24 weeks and during a long‐term extension period without increasing hypoglycaemia. The study confirmed that tolerability in the one‐step group was at least similar to the two‐step dose increase, with nausea/vomiting and hypoglycaemia frequency being lower in the one‐step regimen.