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Phase II Results Show Once-Daily Dosing of Human GLP-1 Analog,Liraglutide, Brings Patients to A1c Target

any diabetes drug for an eight- week period. Patients were then randomized to receive one of four once-daily doses of liraglutide (0.1, 0.3, 0.6, and 0.9 mg) or placebo. Baseline A1c levels ranged between 8.1 to 8.5%. The randomized, 14-week study showed statistically significant dose-dependent reductions in A1c levels (ranging from 0.79 to 1.85 percentage points - placebo adjusted, p<0.0001) after once- daily dosing of liraglutide monotherapy in these patients. Further, A1c levels below 7 percent were achieved by 22, 43, 62 and 75 percent of patients receiving liraglutide 0.1, 0.3, 0.6 and 0.9 mg/day compared with 9 percent of those receiving placebo. Additionally, in these normal-weight subjects (average BMI 23.9) no relevant changes in body weight or major or minor hypoglycemic events occurred in any study group.(1)

The main gastrointestinal adverse events in the high dose group versus placebo were: constipation (7% versus 9%), diarrhea (9% versus 4%), gastritis (7% vs. 0%) and nausea (7% versus 2%). No subject had a treatment-related increase in liraglutide antibodies.

About liraglutide

Currently in phase 3 clinical trials, liraglutide is a human analog of the naturally occurring hormone, Glucagon-Like Peptide-1 (GLP-1), which is rapidly broken down in the body and thus not practical as a therapy for type 2 diabetes. GLP-1 is released from the gastrointestinal tract upon ingestion of food. When glucose levels become too high, GLP-1 triggers the release of insulin from the pancreas and decreases the secretion of glucagon, a hormone that promotes glucose synthesis in the liver. GLP-1 releases insulin in a glucose-dependent manner, meaning that it only triggers insulin secretion if blood glucose is too high. This characteristic is thought to result in a low risk of hypoglycemia, which has been confirmed in a number of studies in which GLP-1 was infused intravenously or subcutaneously.

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