T2DM, Obesity, IL-18, Monoclonal antibody (mAb), Efficacy

• Research type

  Research Study

• Full title

  A Single Blind (Sponsor-unblinded), Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of GSK1070806 in the Treatment of Obese Subjects with T2DM.

• IRAS ID

  105506

• Contact name

  Odile Dewit

• Eudract number

  2012-000126-22

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Type 2 diabetes (T2DM) is a disease characterised by high glucose levels due to an altered insulin action (the principal hormone which keeps glucose under control).To treat T2DM effectively, subjects need to receive treatments which control their blood glucose. This will help to reduce the serious complications (mainly on the heart, eyes or kidney) associated with sustained high glucose concentrations in the body. This study will be the first investigation of GSK1070806 an IL-18 monoclonal antibody, in obese subjects 18-70 years old (men and women) with T2DM and is designed to investigate the efficacy, safety and tolerability of two repeat intravenous doses of the study drug. Research shows that chronic subclinical inflammation plays an important role in the pathogenesis of T2DM - GSK1070806 is expected to reduce this inflammation which will help to reduce high glucose levels and prevent progression to serious complications. The patients to be accepted in the study need to be on a stable dose of Metformin and have no advanced complication related to diabetes. GSK 1070806 has been previously given to healthy volunteers and obese subjects and in terms of side effects no real difference was found compared to a dummy drug. The eligible patients will be allocated randomly to receive two doses by infusion twenty eight days part either of 0.25 mg/kg or 5mg/kg of GSK 1070806 or placebo. The patients and the study team will not know which treatment was allocated until the end of the trial. For each patient they will be approximately 13 study visits from screening until last follow- up visit over a period of approximately 240 days. The trial is funded by GlaxoSmithKline (GSK) and it is multinational (Europe). In the UK, approximately 18 patients will be recruited via NHS consultants and non NHS research centres, including via advertisements.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  12/EE/0226

• Date of REC Opinion

  24 Jul 2012

• REC opinion

  Further Information Favourable Opinion