Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644501
• Other study ID #: 910
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2008
• Last updated: July 10, 2013
• Start date: September 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Andromeda Biotech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.

• Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations = 0.20 nmol/L.

Exclusion Criteria:

• The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.

• The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• DiaPep277
1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.

Locations

Country	Name	City	State
Israel	Wolfson Medical Centre	Holon
Israel	Diabetic Unit, Hadassah Medical Center	Jerusalem
Israel	Schneider Children's Medical Centre	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Andromeda Biotech Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion.		every 6 months up to 24 months from T0	No
Secondary	improved metabolic control and the insulin dose required to maintain it.		every 3 months up to 24 months from T0	No