Phase 3
Completed N=457
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Source: ClinicalTrials.gov NCT00615264 ↗Enrolled (actual)
457
Serious AEs
8.8%
Results posted
Jun 2016
Primary outcomePrimary: Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months — -3.848; -4.348 nmol*minute/L — p=0.2851
◆ Published Evidence
Established
62citations · ~5 / year
Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial.
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.
Linked Publications (2)
-
Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial.
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Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal.
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 |
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) and the linked publication. 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. Informational only — not medical advice.