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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) Juvenile Diabetes Research Foundation American Diabetes Association |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00505375 |
The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Drug: CTLA-4 Ig Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of CTLA-4 Ig (Abatacept) On The Progression of Type 1 Diabetes In New Onset Subjects |
Estimated Enrollment: | 108 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Intravenous infusions of CTLA-4 Ig
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Drug: CTLA-4 Ig
Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
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2: Placebo Comparator
Intravenous infusions of placebo
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Other: Placebo
Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
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Type 1 diabetes mellitus (T1DM) is a T-cell mediated autoimmune disease in which insulin-producing beta cells are completely or near completely destroyed resulting in life-long dependence on exogenous insulin.
CTLA4-Ig (Abatacept) inhibits a crucial stimulatory pathway in the activation of T cells. By this mechanism, the drug is thought to arrest or slow the T cell mediated autoimmune destruction of beta-cells and preserve their function. At the time of clinical onset of T1DM, a significant amount of insulin producing beta cells are destroyed, but as many as 10-20% are still capable of insulin production. By using CTLA4-Ig close to the onset of T1DM, we hope to arrest or slow down the autoimmune destruction of these beta-cells and extend the endogenous insulin production. CTLA4-Ig regulates T cell function but does not deplete T cells. Therefore, its safety profile appears to be better than other immunosuppressive agents.
Eligible participants will be randomized to the experimental or control groups. The experimental group will receive intravenous infusions of CTLA-4 Ig. The first infusion will occur at the time of randomization, followed by another infusion 2 and 4 weeks later. Subsequent infusions will be given monthly for two years during the treatment phase of the study. There is a total of 27 infusions during the treatment phase of the study.
Participants in the control group will receive intravenous infusions of placebo according to the same schedule outlined above.
Both groups will receive standard intensive diabetes treatment with insulin and dietary management.
All participants randomized into the study will be seen at study site monthly for 24 months and then every 6 months for up to an additional 2 years. Participants will undergo assessments of their insulin production, immunologic status, overall health and well being and diabetes care.
Ages Eligible for Study: | 6 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
University of California - San Francisco | |
San Francisco, California, United States, 94143 | |
Childrens Hospital Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Colorado | |
The Barbara Davis Center for Childhood Diabetes | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33136 | |
University of Florida | |
Gainesville, Florida, United States, 32610-0296 | |
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Columbia University, Naomi Berrie Diabetes Center | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
University of Pittsburgh, Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
University of Texas, Southwestern Medical School | |
Dallas, Texas, United States, 75235-8858 | |
United States, Washington | |
Benaroya Research Institute | |
Seattle, Washington, United States, 98101 | |
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G-1X8 |
Principal Investigator: | Tihamer Orban, MD | Joslin Diabetes Center |
Study Chair: | Jay Skyler, MD | University of Miami |
Responsible Party: | Joslin Diabetes Center ( Tihamer Orban, MD ) |
Study ID Numbers: | CTLA |
Study First Received: | July 20, 2007 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00505375 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CTLA4-Ig Abatacept Beta-cell function T-cells DPT-1 treatment treatment of type 1 diabetes |
new onset type 1 diabetes juvenile diabetes T1D diabetes mellitus Type 1 diabetes TrialNet TrialNet |
Metabolic Diseases Autoimmune Diseases Immunologic Factors Diabetes Mellitus Disease Progression Endocrine System Diseases Diabetes Mellitus Type 1 Immunosuppressive Agents |
Cytotoxic T-lymphocyte antigen 4 Abatacept Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Antirheumatic Agents Metabolic Disorder |
Metabolic Diseases Autoimmune Diseases Immune System Diseases Immunologic Factors Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases |
Immunosuppressive Agents Pharmacologic Actions Abatacept Diabetes Mellitus, Type 1 Therapeutic Uses Glucose Metabolism Disorders Antirheumatic Agents |