NIH announces type 1 diabetes clinical trial
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Posted by Andra on 21:19:28 2006/04/26
NIH announces type 1 diabetes clinical trial
The National Institute of Diabetes and Digestive and Kidney Diseases seeks collaboration with industry to provide anti-CD3 for use in a NIH-sponsored multi-center trial to evaluate the effects of anti-CD3 and exenatide on the loss of insulin production in patients with recent onset type 1 diabetes mellitus and in people at high-risk for the development of type 1 diabetes. Collaborations will take the form of clinical trial agreements or cooperative research and development agreements.
The goal of the pilot study is to determine whether treatment of new-onset type 1 diabetes with anti-CD3 plus exenatide is feasible and has an acceptable adverse event profile. The primary goal of the full-scale study is to compare beta cell function (simulated C-peptide response) in the treatment versus control groups. The subsequent trial, which will be performed in high-risk individuals, will assess time to development of type 1 diabetes. Written capability statements should be received before June 1, 2006.
Other sites FBO announcement Reference-Number-DK06-0385.
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