Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme

Aug 7, 2012Diabetes, obesity & metabolism

Weight changes with liraglutide compared to other diabetes treatments in seven clinical trials

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Abstract

24.4% of subjects treated with liraglutide 1.8 mg experienced greater than 5% weight loss during the trials.

Liraglutide at doses of 1.2 mg and 1.8 mg led to more weight loss compared to most active comparators, except exenatide.
Higher initial body mass index (BMI) was associated with slightly greater weight loss in subjects using liraglutide.
Mean weight loss increased slightly with the duration of gastrointestinal adverse events.
Although reductions in glycosylated hemoglobin (HbA1c) were observed across different weight loss categories, sample sizes were small and no definitive correlation was established.
Subjects treated with liraglutide showed HbA1c reductions that were not solely explained by weight loss.

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AIM: We investigated the relationship between weight change and related factors in subjects with type 2 diabetes mellitus (T2DM) treated with liraglutide versus comparator diabetes therapies.

METHODS: Twenty-six-week data from seven phase 3, randomized trials in the liraglutide T2DM development programme were analysed by trial and treatment group: liraglutide (1.2 and 1.8 mg), active comparator and placebo. Outcome measures included proportions of subjects in various weight change categories and their percentage weight change from baseline; impact of body mass index (BMI) and gastrointestinal (GI) adverse events (AEs) on weight change and correlation of weight change with change in glycosylated haemoglobin (HbA1c).

RESULTS: A number of subjects experienced >5% weight loss during the trials (24.4% liraglutide 1.8 mg and 17.7% liraglutide 1.2 mg; 17.7% exenatide, 10.0% sitagliptin, 3.6-7.0% sulphonylurea, 2.6% thiazolidinedione and 2.6% glargine; 9.9% placebo). More weight loss was seen with liraglutide 1.2 and 1.8 mg than with active comparators except exenatide. Across trials, higher initial BMI was associated with slightly greater weight loss with liraglutide. Mean weight loss increased slightly the longer GI AEs persisted. Although HbA1c reduction was slightly larger in higher weight loss categories across treatments (including placebo), sample sizes were small and no clear correlation could be determined. Liraglutide-treated subjects experienced additional HbA1c reduction beyond that which appeared weight induced; thus, not all HbA1c-lowering effect appears weight mediated.

CONCLUSIONS: The majority of liraglutide-treated T2DM subjects experienced weight loss in this analysis. Weight loss was greater and occurred more in glucagon-like peptide-1 receptor agonist-treated subjects than in active comparator-treated subjects.

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Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme

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