Clinical Trial with Diamyd Protocol: D/P3/07/4

• Research type

  Research Study

• Full title

  A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus

• IRAS ID

  7053

• Contact name

  James Greening

• Sponsor organisation

  Diamyd Therapeutics AB

• Eudract number

  2007-002728-13

• Clinicaltrials.gov Identifier

  NCT00723411

• Research summary

  Type 1 diabetes (T1D) is an autoimmune disease, where the body??s insulin-producing cells in the pancreas ?beta cells? are destroyed by the own immune system. Eventually the body cannot supply itself with insulin anymore and the patient needs to inject insulin several times a day for the rest of his/her life. Despite insulin treatment many patients with T1D develop life threatening and debilitating diabetes complications, such as hypoglycemia, blindness and kidney failure. It is known that patients with some remaining ability to produce insulin have a much lower risk to develop complications.Diamyd© is an investigational drug which has been shown to slow down the destructive immune process in patients with T1D and animal models of the disease. By intervening early in the disease process some insulin producing capacity may be saved, which makes the disease easier to manage and reduces the risk for diabetes complications.The proposed research is to perform a Phase III study in children and adolescents with T1D to confirm the results of previous studies. Each patient will be followed for 30 months in total. The trial will enrol 320 patients across nine EU countries, including the UK, of which 2/3 will receive active drug and 1/3 will receive placebo. Four injections of study medication will be administered. The participants must be 10-20 years of age, have been diagnosed with T1D within the previous 3 months, have some remaining insulin producing capacity and have certain biomarkers of auto-immunity in their blood.The main objective of the study is to see if the investigational drug can preserve the insulin producing capacity in patients receiving active drug compared to patients receiving placebo. This is primarily evaluated by the change in insulin production (measured as C-peptide) from the start of the study.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  08/H0206/71

• Date of REC Opinion

  29 Dec 2008

• REC opinion

  Further Information Favourable Opinion