Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial.

ABSTRACT: AIMS:Compare effects of liraglutide 1.8?mg and sulphonylurea, both combined with metformin, on glycaemic control in patients with type 2 diabetes (T2D) fasting during Ramadan. MATERIALS AND METHODS:In this up to 33-week, open-label, active-controlled, parallel-group trial, adults [glycated haemoglobin (HbA1c) 7%-10% (53-86?mmol/mol); body mass index ?20?kg/m(2) ; intent to fast] were randomized (1:1) ?10?weeks before Ramadan to either switch to once-daily liraglutide (final dose 1.8?mg) or continue pre-trial sulphonylurea at maximum tolerated dose, both with metformin. PRIMARY ENDPOINT:change in fructosamine, a validated marker of short-term glycaemic control, during Ramadan. RESULTS:Similar reductions in fructosamine levels were observed for both groups during Ramadan [liraglutide (-12.8?µmol/L); sulphonylurea (-16.4?µmol/L); estimated treatment difference (ETD) 3.51?µmol/L (95% CI: -5.26; 12.28); p?=?0.43], despite lower fructosamine levels in the liraglutide group at start of Ramadan. Fewer documented symptomatic hypoglycaemic episodes were reported in liraglutide-treated (2%, three subjects) versus sulphonylurea-treated patients (11%, 18 subjects). No severe hypoglycaemic episodes were reported by either group. Body weight decreased more during Ramadan with liraglutide (ETD: -0.54?kg; 95% CI: -0.94;-0.14; p?=?0.0091). The proportion of patients reporting adverse events was similar between groups. Liraglutide led to greater HbA1c reduction [ETD: -0.59% (-6.40?mmol/mol), 95% CI: -0.79; -0.38%; -8.63; -4.17?mmol/mol; p?

SUBMITTER: Azar ST 

PROVIDER: S-EPMC5095865 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature