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Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Not Recruiting
Trial ID: NCT01030861
Purpose
The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.
Official Title
AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
* Between ages of 8-45 years
* Have a relative with type 1 diabetes
* If first degree relative must be 8-45 years old (brother, sister, parent, offspring)
* If second degree relative must be between 8-20 years old (niece, nephew, aunt, uncle, grandchild, cousin)
* Abnormal glucose tolerance by OGTT confirmed with 7 weeks of baseline visit \[fasting blood glucose greater than 110mg/dL or and less than 126 mg/dL OR 2 hour glucose greater or equal to 140 mg/dL and less than 200 mg/dL OR 30, 60, or 90 minute value on OGTT greater than or equal to 200 mg/dL\]
* Presence of at least two confirmed diabetes autoantibodies
Exclusion Criteria:
* type 1 diabetes previously diagnosed or detected at screening \[fasting glucose greater or equal to 126 mg/dL or 2 hour glucose greater or equal to 200 mg/dL\]
* abnormalities in blood counts, liver enzymes, international normalised ratio (INR),
* positive purified protein derivative (PPD) test
* vaccination with live virus within 6 weeks of randomization
* evidence of acute infection based on laboratory testing or clinical evidence
* serological evidence of past current or past HIV , hepatitis B, or hepatitis C infection
* Be currently pregnant or lactating
* Prior treatment with study drug
* Prior treatment with other monoclonal antibody in past one year
Intervention(s):
drug: Teplizumab
drug: Placebo infusion
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey, RN
650-498-4450