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 Insulin Dose 15 months HbA1c 15 months
Related Research Topics
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Trial Locations
- Locations (43)
University of Arizona
🇺🇸Tucson, Arizona, United States
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Alex Endocrine Associates
🇺🇸Rogers, Arkansas, United States
Children's Hospital Orange County
🇺🇸Orange, California, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, United States
Christina Care Research institute
🇺🇸Newark, Delaware, United States
University of Florida
🇺🇸Gainsville, Florida, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Scroll for more (33 remaining)University of Arizona🇺🇸Tucson, Arizona, United States