Randomized Phase II study of SRT2104 in Type 2 Diabetes

• Research type

  Research Study

• Full title

  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

• IRAS ID

  18367

• Sponsor organisation

  Sirtris Pharmaceuticals, Inc.

• Eudract number

  2009-010720-26

• Research summary

  Type II diabetes is an epidemic throughout the world. The World Health Organization (WHO) projects that by 2030, over 360 million people worldwide will have type II diabetes.Current therapies do not adequately address insulin resistance associated with type II diabetes and a significant unmet medical need exists for novel mechanism of action therapies to treat metabolic diseases, such as type II diabetes. SRT2104 is thought to work by affecting specific proteins which overall affect glucose metabolism. SRT2104 has also been shown to lower blood glucose. This study is a multi-center, clinical study of SRT2104 administered orally, once daily, for 28 consecutive days; randomized, placebo-controlled, double-blind, multiple-dose, inpatient/outpatient study to assess the safety and pharmacokinetics of SRT2104 in type II diabetic male and female subjects on an existing, stable, background metformin therapy.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  09/H1005/43

• Date of REC Opinion

  6 Jul 2009

• REC opinion

  Further Information Favourable Opinion