Endpoint for Diabetes Trials Remains Glycemic Control

Despite the controversy surrounding GlaxoSmithKline’s diabetes drug Avandia, sponsors will not have to worry, for now, about adding cardiovascular outcomes as a primary endpoint for diabetes drugs they’re developing, according to FDA officials. Sponsors should continue to use glycemic control as the primary endpoint for studies of diabetes drugs, Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, said at a conference on safety assessments in developing drugs for Type 2 diabetes.
Clinical Trials Advisor