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

Completed · Phase 2 · Has a placebo group

Conditions studied: Autoantibody Positive, Non-diabetic Relatives at Risk for Type 1 Diabetes, High Risk, Impaired Glucose Tolerance

In brief

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.

Key facts

Study ID

NCT01030861

Run by

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

People needed

76

Starts

2010-08-01

Expected to finish

2019-06-01

Last updated by the study team

2020-08-05

Who can join

Age: 8 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California in San Francisco — San Francisco, California, United States
• University of California-San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes/ University of Colorado — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Columbia University — New York, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Benaroya Research Institute — Seattle, Washington, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Forschergruppe Diabetes — Munich, Germany

Full record on ClinicalTrials.gov

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