Once-daily liraglutide lowers Hb[A.sub.1c] by 1.7% in early trial.WASHINGTON -- A new glucagonlike peptide-1 agonist known as liraglutide significantly reduced Hb[A.sub.1c] when used as monotherapy in a phase II trial that was presented at the annual scientific sessions of the American Diabetes Association.
Liraglutide, an incretin mimetic mimetic /mi·met·ic/ (mi-met´ik) pertaining to or exhibiting imitation or simulation, as of one disease for another.
1. Of or exhibiting mimicry.
2. developed by Novo Nordisk A/S for once-daily injection, entered phase III testing in February.
The GLP-1 agonist exenatide (Byetta, Amylin Pharmaceuticals Inc. and Eli Lilly and Co.), approved last year by the Food and Drug Administration for use in type 2 diabetes type 2 diabetes
See diabetes mellitus. , is administered via twice-daily injection.
Dr. Tina Vilsboll of Gentofte University Hospital in Copenhagen and her associates evaluated liraglutide in a 14-week randomized controlled trial A randomized controlled trial (RCT) is a scientific procedure most commonly used in testing medicines or medical procedures. RCTs are considered the most reliable form of scientific evidence because it eliminates all forms of spurious causality. involving 165 patients.
Liraglutide is 97% homologous to native GLP-1 but has two important alterations, she noted. These differences give the analogue a half-life of 12 hours, which makes once-daily dosing possible.
The 1-minute half-life of native GLP-1 means that, for diabetic patients, it would need to be administered via an impractical continuous pump infusion, she noted.
At the highest dose (1.9 mg), there was a mean drop in Hb[A.sub.1c] of 1.7 percentage points, compared with placebo.
Dr. Vilsboll called the absence of hypoglycemia hypoglycemia: see diabetes.
Below-normal levels of blood glucose, quickly reversed by administration of oral or intravenous glucose. Even brief episodes can produce severe brain dysfunction. especially noteworthy. Nausea--experienced by 10% of patients--and diarrhea were the most common side effects.
Also notable was a linear reduction in body weight, with no plateau, Continued therapy would likely show even greater weight loss, she speculated.
At a press briefing, ADA vice president Dr. John B. Buse of the University of North Carolina at Chapel Hill The University of North Carolina at Chapel Hill is a public, coeducational, research university located in Chapel Hill, North Carolina, United States. Also known as The University of North Carolina, Carolina, North Carolina, or simply UNC commented that the weight loss seen with liraglutide was as high as 20-30 kg (44-66 pounds) in some patients, although others had no weight loss.
Dr. Vilsboll observed that diabetes causes beta cells to deteriorate by 4% every year. Her group conducted a subanalysis of beta-cell function, which showed increased function of these cells in type 2 diabetics; the improvements were most significant with the two highest doses of liraglutide. "This is not just a coincidence, because by now a lot of studies with native GLP-1 have shown that this drug does have a beneficial effect in the beta cells," she said.
BY JOHN R. BELL