Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 receptor agonist, in African-American people with Type 2 diabetes: a meta-analysis of sub-population data from seven phase III trials: M. E. Shomali et al.

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Abstract

Aim

To evaluate the efficacy and safety of the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide in African-American people with Type 2 diabetes.

Methods

Analyses were performed on patient-level data from individuals self-defined as African-American or non-African-American in seven phase III studies. Endpoints included change in HbA1c level, fasting plasma glucose level and body weight from baseline, proportion of patients reaching HbA1c target [< 53 mmol/mol (< 7.0%)], and incidence of hypoglycaemia and nausea. Analyses used data obtained after 26 weeks. Within-population comparisons of liraglutide were performed vs placebo for African-American and non-African-American patient groups. In addition, between-population comparisons with non-African-American patients were performed for each treatment.

Results

In African-American patients (n = 225), HbA1c was significantly reduced at 26 weeks with liraglutide 1.2 and 1.8 mg (−11 and −14 mmol/mol, respectively compared with placebo; P < 0.0001). There were also significant reductions in fasting plasma glucose (−2.4 and −3.1 mmol/l, respectively, compared with placebo; P < 0.0001). Statistically significant reductions in body weight were observed with 1.8 mg liraglutide (−2.1 kg compared with placebo; P = 0.0056), but not with 1.2 mg liraglutide (−0.26 kg; P = 0.7307). The P value for interaction between treatment and race was significant for body weight (P = 0.0355). The incidence of non-severe hypoglycaemia with liraglutide was low (11–15% of patients), and < 25% of patients receiving liraglutide experienced nausea.

Conclusions

This meta-analysis suggests that liraglutide is well tolerated and efficacious for treatment of Type 2 diabetes in African-American patients, with an efficacy that was shown not to differ from that observed in non-African-American patients over 26 weeks.

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