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| 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: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT01030861 |
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 |
| Estimated Enrollment: | 170 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2014 (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
|
The study plans to enroll approximately 140-170 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
positive PPD test
Contacts and Locations| Contact: Jay S Skyler, MD | 305-243-6146 | jskyler@miami.edu |
| Contact: Lisa E Rafkin, MS | 305-243-6146 | lrafkin@miami.edu |
| 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: Celia Hamilton, RN 415-476-5026 HamiltonC@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 | |
| Contact: Amy Wallace, RN | |
| Principal Investigator: Peter Gottleib, MD | |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States | |
| Contact: Laurie Feldman, RN 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: Jessica Ferguson, RN 352-334-0866 jaycee@ufl.edu | |
| Principal Investigator: Desmond Schatz, MD | |
| University of Miami | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Della Matheson, RN 305-243-3781 dmatheso@miami.edu | |
| Principal Investigator: Jennifer Marks, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Maria Nicholson, RN malnicho@iupui.edu | |
| Principal Investigator: Linda DiMeglio, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Jennifer Smith, RN 612-624-6682 smit5759@umn.edu | |
| Principal Investigator: Toni Moran, 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 | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15201 | |
| Contact: Karen Riley, RN 412-692-5210 karen.riley@chp.edu | |
| Principal Investigator: Dorothy Becker, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States | |
| Contact: Margo Black, RN, CDE | |
| Principal Investigator: William Russell, MD | |
| United States, Texas | |
| University of Texas | Not yet recruiting |
| Dallas, Texas, United States, 75390-9072 | |
| Contact: Marilyn Alford, RN 214-648-4844 MarilynAlford@UTSouthwestern.edu | |
| Principal Investigator: Philip Raskin, MD | |
| United States, Washington | |
| Benaroya Research Institute | Recruiting |
| Seattle, Washington, United States, 982101 | |
| Contact: Marli McCulloch | |
| 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 | |
| Study Chair: | Kevan Herold, MD | Yale School of Medicine |
More Information
| Responsible Party: | Ellen Leschek, NIDDK/NIH |
| ClinicalTrials.gov Identifier: | NCT01030861 History of Changes |
| Other Study ID Numbers: | TrialNet - tep (IND) |
| Study First Received: | December 11, 2009 |
| Last Updated: | February 10, 2012 |
| Health Authority: | United States: Federal Government |
|
type 1 diabetes pre-diabetic autoantibody positive |
at risk for type 1 diabetes glucose intolerance relatives of people with type 1 diabetes |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Hyperglycemia |
