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



Status:Active, not recruiting
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:8 - 45
Updated:7/11/2018
Start Date:August 2010
End Date:January 2019

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

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.

The study plans to enroll approximately 71 subjects between the ages of 8-45 years, over 2-3
years. The study is projected to last between 4-6 years, depending upon rate of enrollment
and number of subjects who develop diabetes.

The main study objective is to determine whether intervention with teplizumab will prevent or
delay the development of type 1 diabetes in high risk autoantibody positive non-diabetic
relatives of individuals with T1D. Secondary outcomes are to include analyses of C-peptide
and other measures from Oral Glucose Tolerance Testing (OGTT), safety, tolerability, and
other mechanistic outcomes will be assessed during the study.

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
We found this trial at
18
sites
116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Robin Goland, MD
Phone: 212-851-5492
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Maria Redondo, MD
Phone: 832-825-3780
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Linda DiMeglio, MD
Phone: 317-278-2551
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Wayne Moore, MD
Phone: 913-406-6803
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Jennifer Marks, MD
Phone: 305-243-3781
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Toni Moran, MD
Phone: 612-626-8467
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Dorothy Becker, MD
Phone: 412-692-5210
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Phone: 813-396-9574
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Dallas, Texas 75235
Principal Investigator: Philip Raskin, MD
Phone: 214-648-4717
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Dallas, TX
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Denver, Colorado 80045
Principal Investigator: Peter Gottleib, MD
Phone: 303-724-6894
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: William Russell, MD
Phone: 615-343-5968
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Kevan Herold, MD
Phone: 203-737-2760
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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San Francisco, California 94143
Principal Investigator: Stephen Gitelman, MD
Phone: 415-502-8640
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San Francisco, California 94143
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Seattle, Washington 98101
Principal Investigator: Carla Greenbaum, MD
Phone: 206-342-6943
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Darrell Wilson, MD
Phone: 650-498-4450
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Diane Wherrett, MD
Phone: 416-813-8159
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