Add-on treatment with liraglutide improves glycemic control without causing major hypoglycemia or weight gain, a trial in patients with Type 2 diabetes has found.

The study suggests that liraglutide, a new once-daily human analogue of glucagon-like peptide-1 (GLP-1), may be a useful new treatment in patients who are suboptimally controlled on sulfonylurea monotherapy.

Liraglutide mimics the glucoregulatory actions of endogenous GLP-1 by targeting the incretin system, and has been shown to bring about sustained improvements in glycemic control, beta-cell function, and weight, with a low risk for hypoglycemia.

The present study evaluated the safety and efficacy of liraglutide in 264 Japanese patients with a mean body mass index of 24.9 kg/m² and mean glycated hemoglobin (HbA1c) level of 8.4%. They were randomly assigned to take liraglutide 0.6 mg/day, liraglutide 0.9 mg/day, or placebo, each added to sulfonylurea monotherapy, for 24 weeks.

At the end of the study period, HbA1c had fallen by 1.56%, 1.46%, and 0.40% in the liraglutide 0.9 mg/day, 0.6 mg/day, and placebo groups, respectively. The differences between active treatment and placebo were statistically significant.

Furthermore, a significantly greater proportion of patients in the liraglutide treatment groups had achieved target HbA1c levels of less than 7.0% (46.5% with lower-dose and 71.3% with higher-dose liraglutide versus 14.8% with placebo).

Liraglutide treatment was also associated with significant reductions in fasting plasma glucose and postprandial plasma glucose.

Finally, overall safety was comparable among the three groups. There were no major hypoglycemic episodes in any group and body weight was unchanged in both liraglutide groups, whereas mean weight fell by 1.12 kg in the placebo group.

Writing in the journal Diabetes, Obesity, and Metabolism, Kohei Kaku (Kawasaki Medical School, Okayama, Japan) and fellow investigators say that liraglutide provides “superior glycemic control” compared with placebo, offering sustained and significant reductions in HbA1c in a dose-dependent manner.

They conclude: “In Japanese subjects with Type 2 diabetes, once-daily liraglutide administered at 0.9 mg/day is both effective and well-tolerated in combination with sulfonylurea agents, demonstrating significantly greater glycemic control than sulfonylurea monotherapy, without causing adverse weight gain or loss.”

A 28-week follow-up study of the study participants is ongoing and will provide long-term safety and efficacy data.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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