Efficacy and safety of liraglutide compared to sulphonylurea during R amadan in patients with type 2 diabetes ( LIRA‐R amadan): a randomized trial

• Published in: Diabetes, obesity & metabolism Vol. 18; no. 10; pp. 1025 - 1033
• Main Authors: Azar, S. T., Echtay, A., Wan Bebakar, W. M., Al Araj, S., Berrah, A., Omar, M., Mutha, A., Tornøe, K., Kaltoft, M. S., Shehadeh, N.
• Format: Journal Article
• Language: English
• Published: 01.10.2016
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12733

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 R amadan. 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 R amadan 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 R amadan. Results Similar reductions in fructosamine levels were observed for both groups during R amadan [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 R amadan. 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 R amadan 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 < 0.0001]. Conclusions Despite lower fructosamine levels and body weight at the beginning of R amadan, use of liraglutide showed similar glycaemic improvements, fewer hypoglycaemic episodes and greater body weight reduction compared with sulphonylurea. LIRA‐R amadan provides evidence for liraglutide being safe and efficacious for management of T2D during R amadan fasting.