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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.

SUBMITTER: Montanya E 

PROVIDER: S-EPMC5067695 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Improvement in glycated haemoglobin evaluated by baseline body mass index: a meta-analysis of the liraglutide phase III clinical trial programme.

Montanya E E   Fonseca V V   Colagiuri S S   Blonde L L   Donsmark M M   Nauck M A MA  

Diabetes, obesity & metabolism 20160202 7


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  ...[more]

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