Clinical Trial Details

Overview

Research Study Summary

AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus

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.

To Learn more

CW ID: 204883
Date Last Changed: January 8, 2015

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
8 to 45 Years
Overall Status
Recruiting
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Facility Type
N/A

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]
  • Labnormalities 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

Contact

Emily Eyth
University of South Florida - USF Diabetes Center
13330 USF Laurel Dr.
Tampa, FL 33612
Phone: (813) 974-2793

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