Status:
TERMINATED
A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT
Lead Sponsor:
Diamyd Therapeutics AB
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
10-20 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Main
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00751842
Start Date
September 1 2008
End Date
July 1 2012
Last Update
October 10 2012
Active Locations (43)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
3
Alex Endocrine Associates
Rogers, Arkansas, United States, 72758
4
Children's Hospital Orange County
Orange, California, United States, 92868