title: Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial.
abstract: 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.
  
  
  
  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.
  
  
  
  change in fructosamine, a validated marker of short-term glycaemic control, during Ramadan.
  
  
  
  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 < 0.0001].
  
  
  
  Despite lower fructosamine levels and body weight at the beginning of Ramadan, use of liraglutide showed similar glycaemic improvements, fewer hypoglycaemic episodes and greater body weight reduction compared with sulphonylurea. LIRA-Ramadan provides evidence for liraglutide being safe and efficacious for management of T2D during Ramadan fasting.
authors.affiliation: Dept. of Internal Medicine, American University of Beirut Medical Centre, Beirut, Lebanon. sazar@aub.edu.lb.
authors.forename: S T
authors.initials: ST
authors.lastname: Azar
authors.affiliation: Dept. of Internal Medicine, Rafik Hariri University, Beirut, Lebanon.
authors.forename: A
authors.initials: A
authors.lastname: Echtay
authors.affiliation: Dept. of Medicine, Universiti Sains Malaysia, Penang, Malaysia.
authors.forename: W M
authors.initials: WM
authors.lastname: Wan Bebakar
authors.affiliation: Obaidulla Hospital, Ras al-Khairmah, United Arab Emirates.
authors.forename: S
authors.initials: S
authors.lastname: Al Araj
authors.affiliation: Dept. of Medicine, University Hospital Bab El Oued, Algiers, Algeria.
authors.forename: A
authors.initials: A
authors.lastname: Berrah
authors.affiliation: Dept. of Diabetes and Endocrinology, University of KwaZulu-Natal, KwaZulu-Natal, Republic of South Africa.
authors.forename: M
authors.initials: M
authors.lastname: Omar
authors.affiliation: Diabetes Care & Research Centre, Nagpur, India.
authors.forename: A
authors.initials: A
authors.lastname: Mutha
authors.affiliation: Medical & Science, GLP-1 & Obesity, Novo Nordisk A/S, Copenhagen, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Tornøe
authors.affiliation: Medical & Science, GLP-1 & Obesity, Novo Nordisk A/S, Copenhagen, Denmark.
authors.forename: M S
authors.initials: MS
authors.lastname: Kaltoft
authors.affiliation: Pediatric Diabetes Unit at Meyer Children's Hospital, Rambam Medical Centre and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.
authors.forename: N
authors.initials: N
authors.lastname: Shehadeh
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D057915:Drug Substitution / Q000379:methods; D004359:Drug Therapy, Combination; D005215:Fasting / Q000378:metabolism; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007514:Islam; D000069450:Liraglutide / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D013453:Sulfonylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D000069450:Liraglutide; D008687:Metformin
keywords: GLP-1; Ramadan; body weight; fasting; fructosamine; hypoglycaemia; liraglutide; metformin; sulphonylurea; type 2 diabetes