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

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 < 0.0001]. CONCLUSIONS: 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.

Hospital-acquired Clostridium difficile infection among patients with type 2 diabetes mellitus in acute medical wards.

BACKGROUND: Clostridum difficile (C. difficile) infection is increasingly seen among hospitalised patients with type 2 diabetes mellitus but its rate and associated risk factors are not known. We aimed to determine the rate and characteristics of hospital-acquired C. difficile infection in subjects with type 2 diabetes mellitus admitted into acute medical wards. METHODS: Our prospective cross-sectional study involved 159 patients with established type 2 diabetes mellitus admitted into acute medical wards who developed a hospital-acquired C. difficile infection. Stools were tested for C. difficile toxins using a toxin A/B kit and a toxin A kit. Clinical features, laboratory findings, types of antibiotics, and use of a proton pump inhibitor were examined for their association with the infection. RESULTS: Thirteen subjects were positive for toxin A and one for toxin B. Using univariable analysis, we found that patients with type 2 diabetes mellitus and hospital acquired C. difficile infection were younger (mean 53.8 years, p=0.02), had diarrhoea and abdominal pain (p=0.001) but no fever. Sepsis (p=0.02) and use of a proton pump inhibitor (p=0.01) were more commonly implicated as the cause of the infection. Of the various types of antibiotics prescribed, carbapenem (28.6% vs 4.1%, p=0.01) and metronidazole (42.9% vs 19.3%, p=0.04) were significantly associated with hospital acquired C. difficile infection. CONCLUSIONS: Patients with type 2 diabetes mellitus admitted into acute medical wards and who developed hospital-acquired C. difficile infection have distinct characteristics.