At a glance
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A Phase II, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
In Brief
A Phase 2 clinical trial evaluating SRT2104 and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 227 participants across 61 sites in 8 countries.
Detailed Summary
The primary purpose of this study is to determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive days, and to characterize the pharmacokinetic profile of SRT2104 after a single dose and multiple administrations in type 2 diabetic subjects. The secondary purpose of this study is to determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects.
Study Details
Timeline
Interventions
SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg.
Placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.