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Design, findings and implications of the liraglutide Phase III clinical trial program

Bruce W Bode

Liraglutide is an analog of the human peptide hormone GLP-1 and a member of the GLP-1 receptor agonists class, which has recently been developed for treatment of Type 2 diabetes (T2D). Incretin-based therapies are an important step forward in the management of T2D as they can provide effective glycemic control without the hypoglycemia and weight gain associated with previous therapies. An extensive program of Phase III clinical trials was developed to test the efficacy and safety of liraglutide across the continuum of care in T2D. These trials have proven liraglutide to be well tolerated and effective in managing glycemia in a variety of treatment combinations and across a wide patient population. The Phase III trial program also demonstrated that liraglutide can provide the additional benefits of weight loss, reduction in systolic blood pressure, improvement in measures of β-cell function and increased treatment satisfaction.