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Review
. 2016 Jul;18(7):707-10.
doi: 10.1111/dom.12617. Epub 2016 Feb 2.

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

E Montanya  1 , V Fonseca  2 , S Colagiuri  3 , L Blonde  4 , M Donsmark  5 , M A Nauck  6
Affiliations
Review

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

E Montanya et al. Diabetes Obes Metab. 2016 Jul.

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.

Keywords: body mass index; glycaemic control; liraglutide; meta-analysis; type 2 diabetes.

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Figures

Figure 1
Figure 1
The relationship between baseline body mass index (BMI) and change in glycated haemoglobin (HbA1c) from baseline for liraglutide 1.8 mg, liraglutide 1.2 mg and placebo in pooled data from the LEAD‐1–6 and Lira–DPP‐4 trials. Data are modelled estimates (95% confidence intervals). †Pooled data were analysed using an analysis of covariance (ancova) model which accounted for age, baseline HbA1c, gender, country, trial and previous type 2 diabetes treatment as covariates. Lira, liraglutide.
Figure 2
Figure 2
Change in glycated haemoglobin (HbA1c) from baseline stratified by baseline body mass index for pooled data from the LEAD 1–6 and Lira DPP‐4 trials for liraglutide 1.2 mg (A), liraglutide 1.8 mg (B) and placebo (C). Data shown are mean with standard error, LOCF, based on summary statistics.
See this image and copyright information in PMC

References

    1. Marre M, Shaw J, Brandle M et al. Liraglutide, a once‐daily human GLP‐1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD‐1 SU). Diabet Med 2009; 26: 268–278. - PMC - PubMed
    1. Nauck M, Frid A, Hermansen K et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)‐2 study. Diabetes Care 2009; 32: 84–90. - PMC - PubMed
    1. Garber A, Henry R, Ratner R et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD‐3 Mono): a randomised, 52‐week, phase III, double‐blind, parallel‐treatment trial. Lancet 2009; 373: 473–481. - PubMed
    1. Zinman B, Gerich J, Buse JB et al. Efficacy and safety of the human glucagon‐like peptide‐1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD‐4 Met + TZD). Diabetes Care 2009; 32: 1224–1230. - PMC - PubMed
    1. Russsell‐Jones D, Vaag A, Schmitz O et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD‐5 met + SU): a randomised controlled trial. Diabetologia 2009; 52: 2046–2055. - PMC - PubMed

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