Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Juvenile Diabetes Research Foundation
American Diabetes Association
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01030861
First received: December 11, 2009
Last updated: April 7, 2016
Last verified: April 2016
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Autoantibody Positive Non-diabetic Relatives at Risk for Type 1 Diabetes High Risk Impaired Glucose Tolerance |
Drug: Teplizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- Criteria are met for diabetes onset as defined by the American Diabetes Association (ADA) based on glucose testing or the presence of unequivocal hyperglycemia with acute metabolic decompensation. [ Time Frame: Elapsed time from random treatment to development of type 1 diabetes (or time of last contact among those enrolled and determined to be eligible) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- effects on teplizumab based on age, gender, race/ethnicity,weight, BMI, immunologic, genetic , demographic, and lifestyle factors. [ Time Frame: Longitudinal analysis will take place over time until diagnosis of diabetes; some secondary outcome measures will be monitored longer such as metabolic and immunological markers. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | January 2022 |
| Estimated Primary Completion Date: | January 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: teplizumab
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
|
Drug: Teplizumab
intravenous infusions
|
|
Placebo Comparator: Placebo infusion
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
|
Drug: Teplizumab
intravenous infusions
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 8 Years to 45 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030861
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030861
Contacts
| Contact: Lisa E Rafkin, MS | 305-243-6146 | lrafkin@miami.edu | |
| Contact: Ryan O'Donnell, MS | ryan.o'donnell@epi.usf.edu |
Locations
| United States, California | |
| University of California in San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Christine Torok, RN 415-502-9089 TorokC@peds.ucsf.edu | |
| Principal Investigator: Steve Gitelman, MD | |
| University of California-San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Kathleen Breen, RN 415-502-8640 breenk@peds.ucsf.edu | |
| Principal Investigator: Stephen Gitelman, MD | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Trudy Esrey, RN 650-498-4450 tesrey@stanford.edu | |
| Principal Investigator: Darrell Wilson, MD | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes/ University of Colorado | Recruiting |
| Denver, Colorado, United States, 80045 | |
| Contact: Jordan Lykens 303-724-6894 jordan.lykens@ucdenver.edu | |
| Principal Investigator: Peter Gottleib, MD | |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Laurie Feldman, MPH 203-737-2760 laurie.feldman@yale.edu | |
| Principal Investigator: Kevan Herold, MD | |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesvillle, Florida, United States, 32610 | |
| Contact: Annie Abraham 352-294-5762 abraa@peds.ufl.edu | |
| Principal Investigator: Desmond Schatz, MD | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Della Matheson, RN 305-243-3781 dmatheso@miami.edu | |
| Principal Investigator: Jennifer Marks, MD | |
| University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Danielle Henson 813-396-9574 dhenson@health.usf.edu | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Bonnie Jagielo, RN 317-278-2551 bjagielo@iu.edu | |
| Principal Investigator: Linda DiMeglio, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Janice Leschyhyn, RN 612-626-8467 lesch004@umn.edu | |
| Principal Investigator: Toni Moran, MD | |
| United States, Missouri | |
| The Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Lois Hester 913-406-6803 lhester@cmh.edu | |
| Principal Investigator: Wayne Moore, MD | |
| Principal Investigator: Mark Clements, MD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Ellen Greenberg, MD 212-851-5492 emg25@columbia.edu | |
| Principal Investigator: Robin Goland, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15201 | |
| Contact: Kelli DeLallo, RN 412-692-5210 kelli.delallo@chp.edu | |
| Principal Investigator: Dorothy Becker, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Anne Brown 615-343-5968 anne.brown@vanderbilt.edu | |
| Principal Investigator: William Russell, MD | |
| United States, Texas | |
| University of Texas | Recruiting |
| Dallas, Texas, United States, 75390-9072 | |
| Contact: Lourdes Pruneda 214-648-4717 Maria.pruneda@utsouthwestern.edu | |
| Principal Investigator: Philip Raskin, MD | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: David Gomez 832-825-3780 david.gomez@bcm.edu | |
| Principal Investigator: Maria Redondo, MD | |
| United States, Washington | |
| Benaroya Research Institute | Recruiting |
| Seattle, Washington, United States, 982101 | |
| Contact: Marli McCulloch 206-342-6943 | |
| Principal Investigator: Carla Greenbaum, MD | |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, MSG-1X8 | |
| Contact: Lesley Eisel, RN 416-813-8159 lesley.eisel@sickkids.ca | |
| Principal Investigator: Diane Wherrett, MD | |
| Germany | |
| Forschergruppe Diabetes | Recruiting |
| Munich, Germany | |
| Contact: Stephanie Zillmer +49(0)89 31874793 stephanie.zillmer@helmholtz-muenchen.de | |
| Principal Investigator: Anette Ziegler, MD | |
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Juvenile Diabetes Research Foundation
American Diabetes Association
Investigators
| Study Chair: | Carla J Greenbaum, MD | Type 1 Diabetes TrialNet |
More Information
Additional Information:
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT01030861 History of Changes |
| Other Study ID Numbers: | TrialNet - tep (IND) |
| Study First Received: | December 11, 2009 |
| Last Updated: | April 7, 2016 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
type 1 diabetes pre-diabetic autoantibody positive |
at risk for type 1 diabetes glucose intolerance relatives of people with type 1 diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Hyperglycemia |
ClinicalTrials.gov processed this record on September 27, 2016