Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum
Brief summary
The intended purpose of this study was 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 diabetes. Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.
Interventions
DRUGrhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
DRUGPlacebo
Placebo injected subcutaneously at days 1, 30, 90 and 270.
Sponsors
Diamyd Therapeutics AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * 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 * Male and female patients between 10 and 20 years of age Main
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meal Stimulated C-peptide (area under the curve) | 15 months |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | 15 months |
| Insulin Dose | 15 months |
Countries
United States
Outcome results
None listed