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

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• 作者：E. Montanya ; V. Fonseca ; S. Colagiuri ; L. Blonde ; M. Donsmark and M. A. Nauck
• 刊名：Diabetes, Obesity and Metabolism
• 出版年：2016
• 出版时间：July 2016
• 年：2016
• 卷：18
• 期：7
• 页码：707-710
• 全文大小：342K
• ISSN：1463-1326

文摘

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/m² up to 45 kg/m²) 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/m² 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.