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

This study has been terminated.
(A corporate decision to suspend development of DiaPep277®)
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT01898286
First received: July 10, 2013
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

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 (NCT01103284)

Resource links provided by NLM:


Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:
  • Hypoglycemic Events [ Time Frame: At Early Termination Visit, Up to 25 Months ] [ Designated as safety issue: Yes ]
    The number of hypoglycemic events recorded by each patient over the course of the study.


Secondary Outcome Measures:
  • Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit [ Time Frame: Baseline and Early Termination Visit, Up to 25 Months ] [ Designated as safety issue: No ]
    Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.


Other Outcome Measures:
  • Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit [ Time Frame: Baseline and Early Termination Visit, up to 25 months ] [ Designated as safety issue: No ]
  • Glycemic Control (Change From Baseline in % HbA1c) [ Time Frame: Baseline and Early Termination Visit, Up to 25 Months ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: October 2013
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DiaPep277®
Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284)
Drug: DiaPep277®
1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations

Detailed Description:

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 (NCT01103284) 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.

  Eligibility

Ages Eligible for Study:   18 Years to 47 Years   (Adult)
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 ≥ 0.20 nmol/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

Locations
United States, Georgia
Atlanta Diabetes associates
Atlanta, Georgia, United States, 30318
United States, Michigan
Henry Ford Medical Centers - New Center One
Detroit, Michigan, United States, 48202
United States, North Carolina
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803
Sponsors and Collaborators
Andromeda Biotech Ltd.
Investigators
Principal Investigator: Itamar Raz, MD Hadassah Medical Center, Jerusalem
  More Information

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
Results First Received: November 16, 2015
Last Updated: April 19, 2016
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: Medicines and Medical Devices Agency
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
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2016