Trial Search Results

Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator: American Diabetes Association

Stanford Investigator(s):

Intervention(s):

  • Drug: Teplizumab

Phase:

Phase 2

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, INR,

   - positive 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

Ages Eligible for Study

8 Years - 45 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Trudy Esrey, RN
650-498-4450
Recruiting