A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00751842
- Run by
- Diamyd Therapeutics AB
- People needed
- 331
- Starts
- 2008-09-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2012-10-10
Who can join
Age: 10 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Miami Children's Hospital Research Institute — Miami, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Atlanta Diabetes Associates — Atlanta, Georgia, United States
- Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
- University of Iowa Hospitals and Clinicals — Iowa City, Iowa, United States
- Mid America Diabetes Associates — Wichita, Kansas, United States
- University of Kentucky College of Medicine — Lexington, Kentucky, United States
- University of Louisville Research Foundation — Louisville, Kentucky, United States
- Children's Hospital — New Orleans, Louisiana, United States
- University of Maryland Medical Center — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- UMass Memorial Medical Center — Worcester, Massachusetts, United States
- University of Michigan Health System — Ann Arbor, Michigan, United States
- Alzohaili Medical Consultants — Dearborn, Michigan, United States
- The Children's Mercy Hospital — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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