Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® (DIA-AID 2)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Andromeda Biotech Ltd.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT01898286
First received: July 10, 2013
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: DiaPep277
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001

Resource links provided by NLM:


Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:
  • adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    the frequency, severity and body system association of adverse events will be evaluated


Secondary Outcome Measures:
  • preservation of beta-cell function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • daily insulin dose, per kg body weight [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • glycemic control [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Hba1c levels, glucose excursions (7-point MAGE) and frequency of patients with HbA1c=<7% will be evaluated


Estimated Enrollment: 300
Study Start Date: September 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DiaPep277
continued treatment with DiaPep277 to patients who were on DiaPep277 or Placebo during the initial phase 3 study 1001
Drug: DiaPep277

  Eligibility

Ages Eligible for Study:   18 Years to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898286

Contacts
Contact: Merana Tamir, Ph.D +972-8-938777 merana@andromedabio.com
Contact: Dana Elias, Ph.D +972-8-938777 dana@andromedabio.com

Locations
United States, Georgia
Atlanta Diabetes associates Not yet recruiting
Atlanta, Georgia, United States
Principal Investigator: Bruce Bode, MD         
United States, Michigan
Henry Ford Medical Centers - New Center One Not yet recruiting
Detroit, Michigan, United States
Contact: Wh         
Principal Investigator: Fred Whitehouse, MD         
United States, North Carolina
Mountain Diabetes and Endocrine Center Not yet recruiting
Asheville, North Carolina, United States
Principal Investigator: Wendy Lane, MD         
Sponsors and Collaborators
Andromeda Biotech Ltd.
Investigators
Principal Investigator: Itamar Raz, MD Hadassah Medical Center, Jerusalem
  More Information

No publications provided

Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT01898286     History of Changes
Other Study ID Numbers: 1010, 2013-002775-17
Study First Received: July 10, 2013
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration
Austria: Austrian Medicines and Medical Devices Agency
Belarus: Ministry of Health
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Ministry of Health, Social and Family Affairs
Italy: The Italian Medicines Agency
Israel: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: National Institute of Medicines
Russia: Ministry of Health of the Russian Federation
Serbia: Agency for drugs and medical devices Serbia
Spain: Spanish Agency of Medicines

Keywords provided by Andromeda Biotech Ltd.:
C peptide
beta cell function
immune modulation of type 1 diabetes
immune intervention in type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014