Dose Ranging study of ACZ885 in Type II Diabetes

• Research type

  Research Study

• Full title

  Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study

• IRAS ID

  19314

• Contact name

  Nicola Lister

• Eudract number

  2009-009889-13

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Type 2 Diabetes Mellitus (T2DM) is a chronic disease; by 2030 it is expected to affect 370 million people worldwide. Diabetes is a condition caused when the body is unable to produce or use insulin to process the glucose (sugar) in the blood properly and so the level of glucose in the blood is too high for good health. Glucose formation, release and utilisationare regulated by the hormone insulin which is made by the beta cells of the pancreas. Pre-clinical data suggests that Interleukin-1?beta (IL-1ǟ÷) stops the pancreatic beta cells from working and can destroy them. Studies have shown that blocking IL-1ǟ÷ with an interleukin 1 receptor antagonist, as well as a neutralising IL-1ǟ÷ antibody, reduced the HbA1c (a measure of blood sugar control) even within a 4-month treatment period. Longer term, the effects of reducing cell death due to IL-1ǟ÷ is expected to lead to preserved ǟ÷ cell function and therefore prevention of disease progression (worsening of the disease). Canakinumab (ACZ885) is a fully human monoclonal antibody which is being developed for the treatment of IL-1ǟ÷ driven inflammatory diseases. It is designed to bind to human IL-1ǟ÷ and thus stops the IL-1ǟ÷ from binding to its receptors. Canakinumab's direct action is expected to stop the destruction of the pancreatic ǟ÷ cells and thus prevent or delay progression of the disease. A total of 600 patients with T2DM who are treatment naive (no diabetic medication) or taking metformin will be recruited into the study, with 60 of these patients coming from the UK. Each patient??s participation is expected to last between 3 and 5.5 years

• REC name

  Wales REC 3

• REC reference

  09/MRE09/21

• Date of REC Opinion

  20 Aug 2009

• REC opinion

  Further Information Favourable Opinion