Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®

Type 1 Diabetes Clinical Trial

— DIA-AID 2  

Official title:

Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01898286
• Other study ID #: 1010
• Secondary ID: 2013-002775-17
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 10, 2013
• Last updated: July 15, 2013
• Start date: September 2013
• Est. completion date: January 2017

Study information

• Verified date: July 2013
• Source: Andromeda Biotech Ltd.
• Contact: Merana Tamir, Ph.D
• Phone: +972-8-938777
• Email: merana[@]andromedabio.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Austrian Medicines and Medical Devices AgencyBelarus: Ministry of HealthCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesHungary: Ministry of Health, Social and Family AffairsItaly: The Italian Medicines AgencyIsrael: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthPoland: National Institute of MedicinesRussia: Ministry of Health of the Russian FederationSerbia: Agency for drugs and medical devices SerbiaSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.

Therefore, in this extension study, patients who complete the 1001 phase 3 study and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.

By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 47 Years

Eligibility

Inclusion Criteria:

• patients with type 1 diabetes who participated in the 1001 study

• residual beta-cell function demonstrated by stimulated C-peptide = 0.20nmol/l.

Exclusion Criteria:

• The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment

• The subject has a history of any kind of malignant tumor.

• The subject has clinical evidence of any diabetes-related complication

• Subject has history of endogenous allergic reactivity:

• The subject has a known immune deficiency

Study Design

Endpoint Classification: Safety/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

Locations

Country	Name	City	State
United States	Mountain Diabetes and Endocrine Center	Asheville	North Carolina
United States	Atlanta Diabetes associates	Atlanta	Georgia
United States	Henry Ford Medical Centers - New Center One	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Andromeda Biotech Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	daily insulin dose, per kg body weight		24 months	No
Other	glycemic control	Hba1c levels, glucose excursions (7-point MAGE) and frequency of patients with HbA1c=<7% will be evaluated	24 months	No
Primary	adverse events	the frequency, severity and body system association of adverse events will be evaluated	24 months	Yes
Secondary	preservation of beta-cell function	endogenous insulin secretion by beta-cells will be evaluated by levels of fasting and stimulated C-peptide. I.V. glucagon and standard liquid meal will be used as stimulation tests.	24 months	No