Clinical Trial Details
| Trial ID: | L6274 |
| Source ID: | NCT01773707 |
| Associated Drug: | Ctla4-Ig (Abatacept) |
| Title: | CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1 |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01773707/results |
| Conditions: | Abnormal Glucose Tolerance|Type 1 Diabetes |
| Interventions: | DRUG: CTLA4-Ig (Abatacept)|DRUG: Placebo |
| Outcome Measures: | Primary: Time From Randomization to Confirmed Abnormal Glucose Tolerance Test, Measured by Oral Glucose Tolerance Test (OGTT): Abnormal Glucose Tolerance is primary endpoint and defined as: 1. Fasting plasma glucose ≥ 110 mg/dL (6.1 mmol/L) and \< 126 mg/dL (7 mmol/L), or 2. 2 hour plasma glucose ≥ 140 mg/dL (7.8 mmol/L) and \< 200 (11.1 mmol/L), or 3. 30, 60, 90 minute plasma glucose during OGTT ≥ 200 mg/dL (11.1 mmol/L), 96 months | Secondary: Change in C-peptide Concentration to Oral Glucose Tolerance Test (OGTT), To Determine whether treatment with Abatacept is superior to placebo with respect to C-peptide response to oral glucose tolerance, 0 time to 30 months |
| Sponsor/Collaborators: | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Juvenile Diabetes Research Foundation |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 212 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION |
| Start Date: | 2013-03 |
| Completion Date: | 2022-12-14 |
| Results First Posted: | 2024-06-06 |
| Last Update Posted: | 2024-06-06 |
| Locations: | University of California - San Francisco, San Francisco, California, 94143, United States|Stanford University Medical Center, Stanford, California, 94305-5208, United States|Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver, Colorado, 80262, United States|Yale Medical School, New Haven, Connecticut, United States|University of Florida, Gainesville, Florida, 32610-, United States|University of Miami School of Medicine, Miami, Florida, 33136, United States|University of Chicago, Chicago, Illinois, 60637, United States|Indiana University-Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Minnesota, Minneapolis, Minnesota, 57931, United States|Columbia University, New York, New York, United States|Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, 15213, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|Vanderbilt University, Nashville, Tennessee, United States|University of Texas Medical Center at Dallas, Dallas, Texas, 75390-8858, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|Benaroya Research Institute at Virginia Mason, Seattle, Washington, 98101, United States|The Hospital for Sick Children, Toronto, Ontario, MSG-1X8, Canada |
| URL: | https://clinicaltrials.gov/show/NCT01773707 |
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