Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults

Study Overview
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Brief Summary
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This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells. Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.

Official Title
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A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: DiaPep277
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of type 1 diabetes within last 6 months Age 20-45 years fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L BMI between 17 and 30 at screening Exclusion Criteria: Significant disease or condition other than type 1 diabetes Diabetes-related complications Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Experimental: DiaPep277<br>Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. | Drug: DiaPep277<br>* 1.0 mg dose in 0.5 mL of solution<br>|
| Placebo Comparator: Placebo<br>Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. | Drug: Placebo<br>* 40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months | Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC. | Baseline and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7% | The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end. | 24 and 25 months | 
| Frequency of Hypoglycemic Events | Total number of days with at least one hypoglycemic event recorded | Baseline to 25 Months | 
| Mean Number of Days With at Least One Hypoglycemic Event |  | Baseline to 25 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta-cells, autoimmune, Diabetes, immunomodulation