The once-daily human glucagon-like peptide-1 analog, liraglutide, improves β-cell function in Japanese patients with type 2 diabetes

摘要

Aims/Introduction: β-cell function was evaluated by homeostasis model assessment of β-cell function (HOMA-B) index, proinsulin:insulin and proinsulin:C-peptide ratios in adult, Japanese type2 diabetes patients receiving liraglutide. Materials and Methods: Data from two randomized, controlled clinical trials (A and B) including 664 Japanese type2 diabetes patients (mean values: glycated hemoglobin [HbA 1c] 8.61-9.32%; body mass index [BMI] 24.4-25.3kg/m 2) were analyzed. In two 24-week trials, patients received liraglutide 0.9mg (n=268) or glibenclamide 2.5mg (n=132; trialA), or liraglutide 0.6, 0.9mg (n=176) or placebo (n=88) added to previous sulfonylurea therapy (trialB). Results: Liraglutide was associated with improved glycemic control vs sulfonylurea monotherapy or placebo. In liraglutide-treated groups in trialsA and B, area under the curve (AUC) insulin0-3h was improved (P<0.001 for all) and the AUC insulin0-3h:AUC glucose0-3h ratio was increased (estimated treatment difference [liraglutide-comparator] 0.058 [0.036, 0.079]). HOMA-B significantly increased with liraglutide relative to comparator in trialB (P<0.05), but not in trialA. The reduction in fasting proinsulin:insulin ratio was 50% greater than in comparator groups. Conclusions: In Japanese type2 diabetes patients, liraglutide was associated with effective glycemic control, restoration of prandial insulin response and indications of improved β-cell function. This trial was registered with Clinicaltrials.gov (trialA: no. NCT00393718/JapicCTI-060328 and trialB: no. NCT00395746/JapicCTI-060324).