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

  • STATUS
    Recruiting
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 8 November 2020

Summary

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

Description

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.

Details
Clinical Study IdentifierTX139945
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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