Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
NCT00948493 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2013-03-20
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™.
Conditions
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
Interventions
- DRUG
-
Buccal insulin spray
Oral insulin spray absorbed in buccal mucosa
Sponsors & Collaborators
-
Generex Biotechnology Corp.
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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