title: Improvement in glycated haemoglobin evaluated by baseline body mass index: a meta-analysis of the liraglutide phase III clinical trial programme.
abstract: In the liraglutide clinical trial programme, liraglutide 1.2 and 1.8 mg 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, 1.8 mg 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 1.2 mg, and a modest, clinically non-relevant, association for liraglutide 1.8 mg [-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.
authors.affiliation: Bellvitge Hospital, CIBERDEM, University of Barcelona, Barcelona, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Montanya
authors.affiliation: Tulane University School of Medicine, New Orleans, LA, USA.
authors.forename: V
authors.initials: V
authors.lastname: Fonseca
authors.affiliation: Boden Institute, University of Sydney, Sydney, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Colagiuri
authors.affiliation: Ochsner Medical Center, New Orleans, LA, USA.
authors.forename: L
authors.initials: L
authors.lastname: Blonde
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Donsmark
authors.affiliation: St. Josef Hospital, Ruhr-University Bochum, Bochum, Germany.
authors.forename: M A
authors.initials: MA
authors.lastname: Nauck
mesh_terms: D015992:Body Mass Index; D017326:Clinical Trials, Phase III as Topic; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D000069450:Liraglutide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage*
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069450:Liraglutide; D000068900:Sitagliptin Phosphate
keywords: body mass index; glycaemic control; liraglutide; meta-analysis; type 2 diabetes