Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes
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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.
A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus
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Resource links provided by the National Library of Medicine
To evaluate the efficacy of Diamyd® 20ug versus placebo with respect to preserving residual insulin secretion as measured by C-peptide levels. The effect of intervention will be evaluated at month 15 (main study period) and at month 30 (Extension phase).
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Layout table for eligibility information
Ages Eligible for Study:
10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)