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 not 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
  • Drug: Placebo infusion

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, 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

Ages Eligible for Study

8 Years - 45 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

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