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

Generex Biotechnology

Status

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Drug: Buccal insulin spray

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00948493

GEN-100-OL

Details and patient eligibility

About

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™.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Study is closed