Phase 3
N=457
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00615264 ↗Enrolled (actual)
457
Serious AEs
8.8%
Results posted
Jun 2016
Primary outcome: Primary: Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months — -3.848; -4.348 nmol*minute/L — p=0.2851
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DiaPep277 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Andromeda Biotech Ltd.
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months |
-3.848; -4.348 | 0.2851 |
| SECONDARY Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months |
-44.33; -43.24 | 0.7690 |
Summary
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of type 1 diabetes for up to 3 months at screening
- Insulin dependency
- Fasting C-peptide levels >= 0.22 nmol/L
- Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)
Exclusion Criteria
- Pregnancy or intent to conceive in the next 2 years
- Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
- Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
Data sourced from ClinicalTrials.gov (NCT00615264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.