Overview

This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatments diapep277, placebo
Phase phase 3
Sponsor Andromeda Biotech Ltd.
Start date April 2010
End date October 2013
Trial size 450 participants
Trial identifier NCT01103284, DiaPep277-1001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
diapep277
1.0 mg dose, administered as subcutaneous injection. Dosing schedule: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
placebo
40 mg mannitol, administered subcutaneously, Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Primary Outcomes

Measure
beta-cell function, measured as change from baseline in stimulated C-peptide secretion (AUC) during a mixed-meal tolerance test
time frame: 25 months after 1st administration

Secondary Outcomes

Measure
Percent of subjects that achieve good glycemic control: HbA1c<7%
time frame: 25 months

Eligibility Criteria

Male or female participants from 20 years up to 45 years old.

Inclusion Criteria: - clinical diagnosis of type 1 diabetes within last 6 months - Age 20-45 years - fasting basal C-peptide equal or greater than 0.22nmol/L, lower than 0.8nmol/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

Additional Information

Official title A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects
Principal investigator Itamar Raz, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Andromeda Biotech Ltd..