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

July 27, 2009
March 18, 2013
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Complete list of historical versions of study NCT00948493 on ClinicalTrials.gov Archive Site
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Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
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™.

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  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
Drug: Buccal insulin spray
Oral insulin spray absorbed in buccal mucosa
Other Name: Generex Oral-lynTM (oral, buccal insulin spray)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
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Study is closed

Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00948493
GEN-100-OL
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Generex Biotechnology Corp.
Generex Biotechnology Corp.
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Generex Biotechnology Corp.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP