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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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00948493
Enrollment
Unknown
Registered
2009-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Keywords

diabetes, insulin therapy

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™.

Interventions

DRUGBuccal insulin spray

Oral insulin spray absorbed in buccal mucosa

Sponsors

Generex Biotechnology Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

Inclusion criteria

Study is closed

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026