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

Expanded access is no longer available for this treatment.
Information provided by (Responsible Party):
Generex Biotechnology Corp. Identifier:
First received: July 27, 2009
Last updated: March 18, 2013
Last verified: March 2013

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™.

Condition Intervention
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Drug: Buccal insulin spray

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Generex Biotechnology Corp.:

Intervention Details:
    Drug: Buccal insulin spray
    Oral insulin spray absorbed in buccal mucosa
    Other Name: Generex Oral-lynTM (oral, buccal insulin spray)

Genders Eligible for Study:   Both

Study is closed

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Generex Biotechnology Corp. Identifier: NCT00948493     History of Changes
Other Study ID Numbers: GEN-100-OL
Study First Received: July 27, 2009
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Generex Biotechnology Corp.:
insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 16, 2014