Sirtris Pharmaceuticals Initiates Phase IIa Diabetes Trial
Sirtris Pharmaceuticals announced a Phase IIa clinical trial in India to evaluate its SRT501 product candidate in Type 2 diabetes whose glucose levels are not adequately controlled by their metformin treatment.
According to Sirtris, patients on metformin alone who have a glycosylated hemoglobin (HbA1c) level greater than 7.5 percent will be allowed to enter the randomized, double-blind, placebo-controlled trial.
The patients will continue their current metformin therapy together with either SRT501 or placebo, which will be administered once-daily for three months.
The trial endpoints will focus on measurements of diabetic status, including fed and fasting glucose, insulin and HbA1c levels.
The company said it expects to enroll 65 patients in each of the SRT501 and placebo arms. Results from this trial are expected at the end of 2008, the company added.
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