By Jill Stein
ROME -- September 8, 2008 -- Once-daily liraglutide used alone significantly boosts glucose control in patients with type 2 diabetes compared with glimepiride, according to results released here at the European Association for the Study of Diabetes (EASD) 2008.
The randomised, 52-week study compared 2 doses of the human glucagon-like peptide analogue liraglutide against the sulfonylurea glimepiride (8 mg QD) in patients with type 2 diabetes.
Alan J. Garber, MD, Baylor College of Medicine, Houston, Texas, presented the results in an oral session on September 8.
The 746 study participants had been previously treated with diet and exercise or had received less than half the maximal dose of a single oral agent.
Previously, phase 2 studies using liraglutide as monotherapy for type 2 diabetes showed substantial improvements in glycaemic control, with low rates of hypoglycaemia and weight loss.
In Dr. Garber's study, the results showed that liraglutide at once-daily doses of 1.2 or 1.8 mg was associated with larger decreases in Hb A1C than glimepiride (P = .0014 and P < .0001, respectively).
Also, more patients in the liraglutide cohorts achieved Hb A1C between 6.5% and 7.0% (P < .01 vs glimepiride).
The 1.8 mg liraglutide dose was associated with a larger decrease in Hb A1C than the 1.2 mg dose (P = .0046).
Mean body weight decreased significantly (P < .001) by 2.05 kg and 2.45 kg with liraglutide 1.2 mg and 1.8 mg, respectively, compared with a 1.12-kg weight gain with glimepiride.
Systolic blood pressure significantly decreased by 2.12 and 3.64 mm Hg in the liraglutide 1.2 and 1.8 mg groups, respectively, compared with a 0.69-mm Hg loss with glimepiride (P < .0001).
The most frequent types of adverse in liraglutide-treated patients were gastrointestinal abnormalities. About 29% of liraglutide-treated patients complained of nausea, however, the incidence decreased during the trial and reached the same levels as glimepiride after 16 weeks.
Patients on liraglutide developed significantly fewer minor hypoglycaemic episodes (<3.1 mmol/L) than the glimepiride group, and no major hypoglycaemic events were reported.
Serious adverse events were reported by 8 patients on liraglutide 1.8 mg, 16 patients on liraglutide 1.2 mg, and 13 patients on glimepiride.
Overall, the results show that liraglutide significantly improves glycaemic control versus glimepiride, reduces body weight, is well tolerated with a low long-term incidence of nausea, and has a lower rate of hypoglycaemia than glimepiride, Dr. Garber concluded.
Funding for this study was provided by Novo Nordisk.
[Presentation title: Significantly Better Glycemic Control and Weight Reduction With Liraglutide, a Once-Daily Human GLP-1 Analogue, Compared With Glimepiride: All as Monotherapy in Type 2 Diabetics. Abstract 896]
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