Status:
COMPLETED
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Lead Sponsor:
Andromeda Biotech Ltd.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
16-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction o...
Eligibility Criteria
Inclusion
- A diagnosis of type 1 diabetes for up to 3 months at screening
- Insulin dependency
- Fasting C-peptide levels \>= 0.22 nmol/L
- Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)
Exclusion
- Pregnancy or intent to conceive in the next 2 years
- Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
- Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT00615264
Start Date
September 1 2005
End Date
January 1 2012
Last Update
June 6 2016
Active Locations (34)
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1
Rudolfstiftung Hospital
Vienna, Austria, 1030
2
Faculty Hospital
Olomouc, Czechia, 775 20
3
Faculty hospital Motol.
Prague, Czechia, 150 06
4
IKEM/Diabetes Centre
Prague, Czechia, 4 140 21