Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® (DIA-AID 2)
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.
|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|
- adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]the frequency, severity and body system association of adverse events will be evaluated
- 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.
- 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
|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)|
continued treatment with DiaPep277 to patients who were on DiaPep277 or Placebo during the initial phase 3 study 1001
Please refer to this study by its ClinicalTrials.gov identifier: NCT01898286
|Contact: Merana Tamir, Ph.Dfirstname.lastname@example.org|
|Contact: Dana Elias, Ph.Demail@example.com|
|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|
|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|
|Principal Investigator:||Itamar Raz, MD||Hadassah Medical Center, Jerusalem|