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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00515099 |
Thymoglobulin is an antibody preparation that is commonly used to treat and prevent organ transplant rejection. The START trial aims to determine whether Thymoglobulin treatment can halt the progression of newly diagnosed type 1 diabetes when given within six weeks of disease diagnosis.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 |
Drug: Antithymocyte globulin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Antithymocyte Globulin on Preserving Beta Cell Function in New Onset Type 1 Diabetes Mellitus |
Estimated Enrollment: | 66 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2015 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Thymoglobulin: Experimental |
Drug: Antithymocyte globulin
Daily 4-day escalating dose
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Placebo: Placebo Comparator |
Drug: Placebo
Daily 4-day saline solution
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Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these cells, the body cannot maintain proper blood glucose levels in response to daily activities, such as eating or exercise. Generally, at the time someone is diagnosed with type 1 diabetes, not all of a person's beta cells have been destroyed - between 15-40% remain healthy and are still able to produce insulin. Importantly, even small amounts of naturally produced insulin can improve blood sugar control, make daily management of diabetes less complicated, and reduce the risk of long term complications. Preserving the remaining precious beta cells is therefore the goal of the START trial.
The medication being tested in the START trial is called Thymoglobulin®, a mixture of specialized proteins called antibodies. Thymoglobulin attaches itself to white blood cells known as T cells, some of which are responsible for the immune system's attack on beta cells that occurs in type 1 diabetes. Thymoglobulin can change how T cells work, and can eliminate a large proportion of the T cells from the bloodstream temporarily. Treatment of new onset type 1 diabetes with Thymoglobulin is therefore expected to alter the behavior of the T cells to halt their attack, and also reduce T cell numbers, so that new T cells that grow in their place will learn to accept the beta cells, rather than attacking them.
Following an initial screening appointment, eligible participants will be randomly assigned to one of two groups: Group 1 will receive the study treatment while Group 2 is a control group that will receive a placebo. Each participant has a 2 in 3 chance of being assigned to the treatment group, and a 1 in 3 chance of being assigned to the placebo. The START trial is a blinded study, so neither participants nor study physicians will know to which group an individual has been assigned. All participants will receive intensive diabetes management. Participants in both groups will be admitted to the hospital for 5-8 days to receive infusions of either the study drug or placebo.
The duration of the study is 2 years. Participants will have 8 follow-up appointments in the first year and 4 visits in the second year. Most of these visits will last 1- 2 hours. A review of interval health, a physical exam, an assessment of diabetes control including recent 5 day insulin use and blood sugar testing, and blood collection for laboratory testing will occur at each visit. Four of the visits will last about 5 hours, during which participants will undergo mixed-meal tolerance testing. This involves drinking a special drink, similar to a milkshake, and having blood specimens taken over a 4-hour period.
Subjects will be reimbursed for travel and parking expenses, and will receive compensation for their participation in the longer mixed meal tolerance test visits.
Ages Eligible for Study: | 12 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marcia Wertz | (415) 514-3597 | info@type1diabetestrial.org |
United States, California | |
Diabetes Center at UCSF | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Kathleen Fraser 415-353-9084 ucsf@type1diabetestrial.org | |
Principal Investigator: Stephen Gitelman, MD | |
UCSD/San Diego Children's Hospital | Recruiting |
San Diego, California, United States, 92123 | |
Contact: Marla Hashiguchi 858-966-8940 ucsd@type1diabetestrial.org | |
Principal Investigator: Michael E. Gottschalk, MD, PhD | |
Principal Investigator: Francine Kaufman, MD | |
Children's Hospital/USC School of Medicine | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Mary Halvorson 323-361-5961 chla@type1diabetestrial.org | |
Contact: Christine Salazar (323) 361-5961 chla@type1diabetestrial.org | |
Children's Hospital and Research Center | Not yet recruiting |
Oakland, California, United States, 92609 | |
Contact: Betty Flores 510-428-3885 ext 4694 oakland@type1diabetestrial.org | |
Principal Investigator: Susan Conrad, MD | |
United States, Colorado | |
Barbara Davis Center for Childhood Diabetes, University of Colorado | Recruiting |
Aurora, Colorado, United States, 80010 | |
Contact: Amy Wallace, MA 303-724-6768 denver@type1diabetestrial.org | |
Principal Investigator: Peter Gottlieb, MD | |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Carrie Gibson 612-624-5958 umn@type1diabetestrial.org | |
Principal Investigator: Antoinette Moran, MD | |
United States, Missouri | |
Children's Mercy Hospital | Recruiting |
Kansas City, Missouri, United States, 64108 | |
Contact: Sue Ellen Weigel 816-234-3975 kansascity@type1diabetestrial.org | |
Principal Investigator: Wayne Moore, MD | |
United States, Pennsylvania | |
University of Pennsylvania/Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Ahmad Khan, RN 215-590-5007 upenn@type1diabetestrial.org | |
Principal Investigator: Steven Willi, MD |
Principal Investigator: | Stephen Gitelman, MD | University of California, San Francisco |
Responsible Party: | DAIT/NIAD ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN028AI |
Study First Received: | August 10, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00515099 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
juvenile diabetes autoimmune diabetes thymoglobulin ATG |
Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Juvenile-Onset Type 1 Diabetes Mellitus |
Antilymphocyte Serum Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |