TN10 Anti-CD3 Prevention (TN10 Anti-CD3 Prevention)
Number of Subjects in Study Archive: 170
Study Design: Clinical Trial
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Prediabetic State
Duration: August 2010 – January 2016
# Recruitment Centers: 15
Treatment: Experimental Anti-CD3 (Teplizumab)
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to samples for TN10 Anti-CD3 Prevention (TN10 Anti-CD3 Prevention) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT01030861
Up to ten percent of all diagnosed diabetics have type 1 diabetes. Type 1 diabetes is a condition that develops due to an autoimmune attack against beta cells in the pancreas, which causes the body to stop producing insulin. Occurring most often in children and young adults, this type of diabetes appears suddenly and can lead to lifelong health complications. Relatives of people with type 1 diabetes have a greater risk of developing the disease. Type 1 Diabetes TrialNet is an international clinical trials network sponsored by NIH which conducts studies to find ways to prevent or delay the development of the disease and to enhance treatment for the newly diagnosed.
Teplizumab (Anti-CD3) is a monoclonal antibody that interferes in the autoimmune attack of pancreatic beta cells. Previous studies have shown that teplizumab reduces the loss of insulin production in type 1 diabetics during the first year after diagnosis. TrialNet 10 is a phase 2 prevention trial of TrialNet, studying the effect of teplizumab on insulin production in the relatives of type 1 diabetics who are at high risk of developing the disease. TrialNet 10 is projected to last 4-6 years with an enrollment period of 2-3 years. The approximate enrollment of the study is 140-170 individuals between the ages of 8-45 years. Subjects will be randomly assigned to either the active or placebo group of the study, and monitored and tested over time until diagnosed with diabetes.
The purpose of the TrialNet 10 study is to determine if teplizumab can help to prevent or delay the onset of type 1 diabetes by prohibiting the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state.
TrialNet 10 will compare the elapsed time from random treatment to development of diabetes between the subjects given teplizumab and those given the placebo. Criteria for diabetes onset are defined by the ADA based on glucose testing or the presence of unequivocal hyperglycemia with acute metabolic decompensation.
The effects of age, gender, race/ethnicity, weight, BMI, immunologic, genetic, demographic, and lifestyle factors on teplizumab will be analyzed over time until the diagnosis of diabetes.
Included individuals must be age 8-45 years, have a first or second degree relative with type 1 diabetes, an abnormal oral glucose tolerance test (OGTT), and the presence of at least two diabetes autoantibodies.
Individuals with type 1 diabetes that has been previously diagnosed or detected at screening; abnormalities in blood counts, liver enzymes, INR; positive PPD test; live virus vaccination within 6 weeks of randomization; evidence of acute infection; past or current HIV, Hepatitis B, or Hepatitis C infection; currently pregnant or lactating; prior treatment with study drug; or treatment in the past year of any monoclonal antibody are excluded from participating in the study.
This study is ongoing.