Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
Primary Purpose
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Buccal insulin spray
Sponsored by
About this trial
This is an expanded access trial for Type 1 Diabetes Mellitus focused on measuring diabetes, insulin therapy
Eligibility Criteria
Study is closed
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00948493
First Posted
July 27, 2009
Last Updated
March 18, 2013
Sponsor
Generex Biotechnology Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00948493
Brief Title
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
Official Title
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Generex Biotechnology Corp.
4. Oversight
5. Study Description
Brief Summary
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™.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Keywords
diabetes, insulin therapy
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buccal insulin spray
Other Intervention Name(s)
Generex Oral-lynTM (oral, buccal insulin spray)
Intervention Description
Oral insulin spray absorbed in buccal mucosa
10. Eligibility
Sex
All
Eligibility Criteria
Study is closed
12. IPD Sharing Statement
Learn more about this trial
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
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