World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01898286
Date of registration: 10/07/2013
Prospective Registration: Yes
Primary sponsor: Andromeda Biotech Ltd.
Public title: Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® DIA-AID 2
Scientific title: Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)
Date of first enrolment: October 2013
Target sample size: 38
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01898286
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Itamar Raz, MD
Address: 
Telephone:
Email:
Affiliation:  Hadassah Medical Center, Jerusalem
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 47 Years
Gender: All
Health Condition(s) or Problem(s) studied
Type 1 Diabetes
Intervention(s)
Drug: DiaPep277®
Primary Outcome(s)
Hypoglycemic Events [Time Frame: At Early Termination Visit, Up to 25 Months]
Secondary Outcome(s)
Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit [Time Frame: Baseline and Early Termination Visit, Up to 25 Months]
Secondary ID(s)
2013-002775-17
1010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 26/05/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01898286
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history