NCT00723411TerminatedPhase 3
A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU)
Diamyd Therapeutics AB65 sites in 8 countries334 target enrollmentStarted: July 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 334
- Locations
- 65
- Primary Endpoint
- Meal stimulated C-peptide (area under the curve)
Study Overview
Brief Summary
The purpose of this study is 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients between 10 and 20 years of age
- •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
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
Arms & Interventions
A
Active Comparator
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on Days 90 and 270.
Intervention: rhGAD65 (Drug)
B
Active Comparator
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on Days 90 and 270.
Intervention: rhGAD65 (Drug)
C
Placebo Comparator
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Meal stimulated C-peptide (area under the curve)
Time Frame: 15 months
Secondary Outcomes
- HbA1c(15 months)
- Insulin Dose(15 months)
Investigators
Study Sites (65)
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