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

Expanded access is no longer available for this treatment.

Sponsor:

Information provided by (Responsible Party):

Generex Biotechnology Corp.

ClinicalTrials.gov Identifier:

NCT00948493

First received: July 27, 2009

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 27, 2009
Last Updated Date	March 18, 2013
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00948493 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
Official Title ^ICMJE	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
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™.
Detailed Description	Not Provided
Study Type ^ICMJE	Expanded Access
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: Buccal insulin spray Oral insulin spray absorbed in buccal mucosa Other Name: Generex Oral-lynTM (oral, buccal insulin spray)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	No longer available
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Study is closed
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00948493
Other Study ID Numbers ^ICMJE	GEN-100-OL
Has Data Monitoring Committee	Not Provided
Responsible Party	Generex Biotechnology Corp.
Study Sponsor ^ICMJE	Generex Biotechnology Corp.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Generex Biotechnology Corp.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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