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

Study Overview
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Brief Summary
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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.

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 (USA)

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: 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

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>|
| 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>|
| 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