Status:
TERMINATED
A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
Lead Sponsor:
Diamyd Therapeutics AB
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
10-20 years
Phase:
PHASE3
Brief Summary
The purpose of this study is 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 di...
Eligibility Criteria
Inclusion
- Main
- Male and female patients between 10 and 20 years of age
- 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
- 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 :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00723411
Start Date
July 1 2008
End Date
August 1 2011
Last Update
October 10 2011
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
Helsinki, Finland, FI-00029
2
Kuopion yliopistollinen sairaala, Lasten klinikka
Kuopio, Finland, FI-70211
3
Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka
Oulu, Finland, FI-90029
4
Seinäjoen keskussairaala, Lastentautien poliklinikka
Seinäjoki, Finland, FI-60220