A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: rhGAD65
* Drug: rhGAD65
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main 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 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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. | Drug: rhGAD65<br>* Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.<br>* Other names: GAD;|
| Active Comparator: B<br>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. | Drug: rhGAD65<br>* Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.<br>* Other names: GAD-Alum;|
| Placebo Comparator: C<br>This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270. | Drug: Placebo<br>* Placebo injected subcutaneously at days 1, 30, 90 and 270<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal stimulated C-peptide (area under the curve) |  | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 15 months | 
| Insulin Dose |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum