- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948493
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
March 18, 2013 updated by: Generex Biotechnology Corp.
An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus
The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL).
This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Study is closed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 27, 2009
First Submitted That Met QC Criteria
July 28, 2009
First Posted (Estimate)
July 29, 2009
Study Record Updates
Last Update Posted (Estimate)
March 20, 2013
Last Update Submitted That Met QC Criteria
March 18, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEN-100-OL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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