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| |  Liraglutide Shows Superiority to Glimepiride for Hypoglycaemia and Weight Loss in Type 2 Diabetes Treatment: Presented at EASD By Bruce Sylvester VIENNA, Austria -- October 1, 2009 -- Two-year treatment of type 2 diabetes with liraglutide plus metformin produces similar improvement in haemoglobin levels as does glimepiride, but with much less hypoglycaemia, researchers reported at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD). Significant weight loss with liraglutide also was sustained, in contrast to weight gain with glimepiride. Lead investigator Anders Frid, MD, PhD, Lund University Diabetes Center, Lund, Sweden, reported these findings in an oral presentation here on September 30. “We saw haemoglobin A1C [Hb A1C] improve in both groups, as expected, but the differences in hypoglycaemia and weight loss between the 2 treatments was striking -- and [it] differentiated them,” he said. The new data are from a 1.5-year extension of an original 6-month study. In the original Liraglutide Effect and Action in Diabetes (LEAD)-2 study, involving 1,091 subjects, results from months of liraglutide treatment were similar to those with glimepiride (both combined with metformin) for glycaemic control. The liraglutide cohort, however, achieved weight reduction, reduced hypoglycaemia, and improved systolic blood pressure. In the extension trial, 780 “completer” subjects from the 26-week trial (89%) were randomised (2:2:2:1:2) to receive liraglutide (0.6, 1.2, or 1.8 mg once daily) plus metformin alone or metformin/glimepiride (4 mg once daily). Metformin dosing was 1.5 to 2 g/day. The first 6 months of the extension study were double-blind and double-dummy. After 6 months, the trial was open-label. Dr. Frid reported that 529 (68%) of the subjects completed 2 years. Prior to entry in the extension trial, subjects had been treated with 1 or 2 oral antidiabetic drugs. Dr. Frid reported that Hb A1C in subjects using 1 oral antidiabetic drug before trial entry (35% of patients, baseline Hb A1C 8.2%) was improved. That improvement was sustained for 2 years; Hb A1C improved to 7.38%, 7.44%, 7.74% for liraglutide 1.8, 1.2, 0.6 mg, respectively, 7.49% for glimepiride and 8.12% for metformin, (P > .05 for liraglutide 1.8 mg vs glimepiride). In the total patient population, the proportion reaching Hb A1C <7.0% after 2 years was 31.1%, 29.9%, 19.7% for liraglutide 1.8, 1.2, 0.6 mg, respectively, 23.5% for glimepiride and 10.8% for metformin (P < .0001 liraglutide 1.8 mg vs glimepiride). Dr. Frid noted that, while it provided similar Hb A1C improvement to glimepiride, through bringing more subjects to target, liraglutide enabled patients to achieve significant and sustained weight loss (1.8 mg, -2.91 kg; 1.2 mg, -3.03 kg; 0.6 mg, -2.07 kg) while glimepiride treatment resulted in weight gain (0.7 kg, P < .0001 vs all liraglutide doses). Additionally, with liraglutide, hypoglycaemia incidence was similar to that seen with metformin monotherapy and 10 times less frequently than that seen with glimepiride (events/subject year: 0.15 [each liraglutide dose]; 0.16 [metformin]; 1.60 [glimepiride], P < .0001 vs all liraglutide doses). “Liraglutide once daily in combination with metformin for 2 years brought comparable improvement in Hb A1C as glimepiride in combination with metformin. However, hypoglycaemia with liraglutide was only a tenth of that with glimepiride and sustained approximately 3 kg weight loss was obtained during the 2 years, in contrast with a small weight gain with glimepiride.” Funding for this study was provided by Novo/Nordisk A/S. [Presentation title: Long-Term Sustained Glycaemic Control With Liraglutide and Glimepiride (Both Plus Metformin), With Added Benefits of Weight Loss and Less Hypoglycaemia With Liraglutide: 2-Year LEAD-2 Data. Abstract 3]
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