Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes

Diamyd Therapeutics

Status and phase

Completed

Phase 2

Conditions

Type 1 Diabetes

Treatments

Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00435981

EUDRACT 2004-003764-30

D/P2/04/3

Details and patient eligibility

About

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 and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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 Criteria:

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)