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

• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus

• Registration Number: NCT00948493
• Lead Sponsor: Generex Biotechnology Corp.

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 available

Study Timeline

• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified