Status:
COMPLETED
Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes
Lead Sponsor:
Diamyd Therapeutics AB
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
10-18 years
Phase:
PHASE2
Brief Summary
This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe a...
Eligibility Criteria
Inclusion
- Key
- Male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months
- Fasting C-peptide level above 0.1 nmol/l
- Presence of GAD65 antibodies
- Written informed consent (patient and parent/guardian)
- Key
Exclusion
- Secondary diabetes mellitus or MODY
- Treatment with immunosuppressants
- Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse)
- HIV or hepatitis
- Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
- Pregnancy (or planned pregnancy within one year after 2nd administration)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00435981
Start Date
January 1 2005
End Date
December 1 2007
Last Update
January 30 2008
Active Locations (8)
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1
Borås Hospital
Borås, Sweden, SE-501 82
2
The Queen Silvia Children´s Hospital
Gothenburg, Sweden, SE-416 85
3
Halmstad Hospital
Halmstad, Sweden, SE-301 85
4
Ryhov Hospital
Jönköping, Sweden, SE-551 85