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Treatment Use of Generex Oral-lyn™ in Patients With Diabetes

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948493
First Posted: July 29, 2009
Last Update Posted: March 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Generex Biotechnology Corp.
July 27, 2009
July 29, 2009
March 20, 2013
 
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
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™.
Not Provided
Expanded Access
Drug: Buccal insulin spray
Oral insulin spray absorbed in buccal mucosa
Other Name: Generex Oral-lynTM (oral, buccal insulin spray)
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00948493
Generex Biotechnology Corp.
Generex Biotechnology Corp.
Not Provided
Not Provided
Generex Biotechnology Corp.
March 2013