A Study in Type 2 Diabetes in Patients on Metformin

• Research type

  Research Study

• Full title

  A multicenter, two-part, randomized, parallel group, placebo and sitagliptin-controlled study to evaluate the safety and efficacy of GSK256073 administered once or twice daily for 12 weeks in subjects with type 2 diabetes mellitus who are being treated with metformin

• IRAS ID

  78783

• Eudract number

  2011-000483-94

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Diabetes is a long-term condition caused by too much glucose, a type of sugar, in the blood.Type 2 Diabetes is caused by either a lack of insulin (hormone that lowers glucose levels) or the body's inability to use insulin efficiently. Carefully controlling the level of glucose in the bloodstream by reducing the amount of blood glucose or making insulin more sensitive to improve glucose absorption could prevent complications of diabetes.Research shows that diabetic patients have higher than normal levels of a particular fat in their body (non-esterified fatty acid, NEFA). Also, the process of ??fat?? breakdown (lipolysis ) continues after a meal which can worsen diabetes by increasing NEFA into the bloodstream. It is thought that'sK256073 works by binding to a receptor in the fat cells which may help stop lipolysis , reduce the level of fatty acids in the blood, make insulin more sensitive and thereby reduce blood glucose.The aim of this 2-part study is to test the safety and glucose-lowering effects of GSK256073 compared to a dummy drug (placebo) when administered to diabetic patients already taking metformin (a commonly used treatment for diabetes), for 12 weeks. Part A will look at the changes to NEFA, glucose and HbA1c (a blood test to check average blood glucose). Part B will proceed based on results from Part A and will study changes in HbA1c and the range of doses used in a larger patient group, comparing GSK256073 to placebo and to sitagliptin (a drug already licensed to treat diabetes). Patients and their doctors will not know which treatment has been randomly selected for them, unless they are receiving sitagliptin in Part B.Each patient enrolled will undergo screening, a 2-week placebo run-in period , baseline assessments, randomisation and a 2 week follow-up period. Total participation in the study will last up to 20 weeks.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0200

• Date of REC Opinion

  23 Jun 2011

• REC opinion

  Further Information Favourable Opinion