A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT
- Registration Number
- NCT00751842
- Lead Sponsor
- Diamyd Therapeutics AB
- Brief Summary
The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.
Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 331
- Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
- Fasting C-peptide level at time of screening above 0.1 nmol/L
- Elevated GAD65 antibodies (GADA) at time of screening
- Male and female patients between 10 and 20 years of age
Main
- Treatment with immunosuppressants or any anti-diabetic medications other than insulin
- A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
- Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
- Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C Placebo This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270. A rhGAD65 This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on days 90 and 270. B rhGAD65 This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on days 90 and 270.
- Primary Outcome Measures
Name Time Method Meal Stimulated C-peptide (area under the curve) 15 months
- Secondary Outcome Measures
Name Time Method HbA1c 15 months Insulin Dose 15 months
Trial Locations
- Locations (43)
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Mid America Diabetes Associates
🇺🇸Wichita, Kansas, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Louisville Research Foundation
🇺🇸Louisville, Kentucky, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Children's Hospital Orange County
🇺🇸Orange, California, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Miami Children's Hospital Research Institute
🇺🇸Miami, Florida, United States
SUNY Institute for Human Performance
🇺🇸Syracuse, New York, United States
University of Iowa Hospitals and Clinicals
🇺🇸Iowa City, Iowa, United States
Alzohaili Medical Consultants
🇺🇸Dearborn, Michigan, United States
CHRISTUS Santa Rosa Children's Hospital
🇺🇸San Antonio, Texas, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Benaroya Research Institute
🇺🇸Seattle, Washington, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Creighton Diabetes Center
🇺🇸Omaha, Nebraska, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Christina Care Research institute
🇺🇸Newark, Delaware, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of Kentucky College of Medicine
🇺🇸Lexington, Kentucky, United States
Naomi Berrie Diabetes Center of Columbia University
🇺🇸New York, New York, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Oklahoma, Schustermann Center Clinic
🇺🇸Tulsa, Oklahoma, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
LeBonheur Children's Medical Center
🇺🇸Memphis, Tennessee, United States
Rocky Mountain Diabetes and Osteoporosis Center
🇺🇸Idaho Falls, Idaho, United States
Kathryn Eckert
🇺🇸Reno, Nevada, United States
University of Florida
🇺🇸Gainsville, Florida, United States
Children's Hospital
🇺🇸New Orleans, Louisiana, United States
St. Louis Children's Hospital
🇺🇸St. Louis, Missouri, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Alex Endocrine Associates
🇺🇸Rogers, Arkansas, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Regional Medical Clinic - Endocrinology
🇺🇸Rapid City, South Dakota, United States