drugset / Trial / NCT00937326

Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects

NCT00937326

Phase 2 Completed 227 enrolled Sirtris, a GSK Company GlaxoSmithKline · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2009-08-19
Primary completion
2010-09-18
Completion
2010-09-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator SRT2104 Small molecule 0.25 g Oral
Comparator SRT2104 Small molecule 0.5 g Oral
Comparator SRT2104 Small molecule 1 g Oral
Comparator SRT2104 Small molecule 2 g Oral