Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5336
Source ID: NCT00751842
Associated Drug: Rhgad65
Title: A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: rhGAD65|DRUG: rhGAD65|DRUG: Placebo
Outcome Measures: Primary: Meal Stimulated C-peptide (area under the curve), 15 months | Secondary: HbA1c, 15 months|Insulin Dose, 15 months
Sponsor/Collaborators: Sponsor: Diamyd Therapeutics AB
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 331
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-09
Completion Date: 2012-07
Results First Posted:
Last Update Posted: 2012-10-10
Locations: University of Arizona, Tucson, Arizona, 85724, United States|Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, 72202, United States|Alex Endocrine Associates, Rogers, Arkansas, 72758, United States|Children's Hospital Orange County, Orange, California, 92868, United States|Rady Children's Hospital, San Diego, California, 92123, United States|Stanford University Medical Center, Stanford, California, 94305, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|Christina Care Research institute, Newark, Delaware, 19713, United States|University of Florida, Gainsville, Florida, 32610, United States|Nemours Children's Clinic, Jacksonville, Florida, 32207, United States|Miami Children's Hospital Research Institute, Miami, Florida, 33155, United States|University of South Florida, Tampa, Florida, 33606, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|University of Iowa Hospitals and Clinicals, Iowa City, Iowa, 52242, United States|Mid America Diabetes Associates, Wichita, Kansas, 67211, United States|University of Kentucky College of Medicine, Lexington, Kentucky, 40536, United States|University of Louisville Research Foundation, Louisville, Kentucky, 40202, United States|Children's Hospital, New Orleans, Louisiana, 70118, United States|University of Maryland Medical Center, Baltimore, Maryland, 21201, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|UMass Memorial Medical Center, Worcester, Massachusetts, 01655, United States|University of Michigan Health System, Ann Arbor, Michigan, 48109, United States|Alzohaili Medical Consultants, Dearborn, Michigan, 48126, United States|The Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|St. Louis Children's Hospital, St. Louis, Missouri, 63110, United States|Creighton Diabetes Center, Omaha, Nebraska, 68131, United States|Kathryn Eckert, Reno, Nevada, 89502, United States|Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Morristown Memorial Hospital, Morristown, New Jersey, 07962, United States|Winthrop University Hospital, Mineola, New York, 11501, United States|Naomi Berrie Diabetes Center of Columbia University, New York, New York, 10032, United States|University of Rochester, Rochester, New York, 14642, United States|SUNY Institute for Human Performance, Syracuse, New York, 13210, United States|Children's Hospital Medical Center of Akron, Akron, Ohio, 44308, United States|University of Oklahoma, Schustermann Center Clinic, Tulsa, Oklahoma, 74135, United States|Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, 15224, United States|Regional Medical Clinic - Endocrinology, Rapid City, South Dakota, 57701, United States|LeBonheur Children's Medical Center, Memphis, Tennessee, 38103, United States|Cook Children's Medical Center, Fort Worth, Texas, 76104, United States|CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas, 78207, United States|Virginia Commonwealth University, Richmond, Virginia, 23219, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States
URL: https://clinicaltrials.gov/show/NCT00751842