Improvement in glycated haemoglobin evaluated by baseline body mass index: a meta-analysis of the liraglutide phase III clinical trial programme
Article
Montanya, E.; Fonseca, V.; Colagiuri, S.; Blonde, L.; Donsmark, M.; Nauck, M. A.
Abstract
In the liraglutide clinical trial programme, liraglutide 1.2 and 1.8mg were found to effectively lower glycated haemoglobin (HbA1c) in patients with type 2 diabetes (T2D). It is unknown whether baseline body mass index (BMI) is a predictor of change in HbA1c observed during a clinical trial with liraglutide or placebo treatment. The present meta-analysis of patient-level data, using pooled data from seven phase III trials [LEAD-1-6 and the liraglutide versus sitagliptin trial (LIRA-DPP-4)] for liraglutide 1.2, 1.8mg and placebo (n= 3222), identified no significant correlation between baseline BMI (< 20 kg/m(2) up to 45 kg/m(2)) and HbA1c reduction for placebo or liraglutide 1.2mg, and a modest, clinically non-relevant, association for liraglutide 1.8mg [-0.010 (95% confidence interval -0.020, -0.001)], whereby a 10 kg/m(2) increase in baseline BMI corresponded to 0.10%-point (1.1 mmol/mol) greater HbA1c reduction. In summary, reductions in HbA1c obtained during clinical trials with liraglutide or placebo treatment were independent of baseline BMI.
