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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Generex Biotechnology Corp.
ClinicalTrials.gov Identifier:
NCT00948493
First received: July 27, 2009
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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)
  Eligibility

Genders Eligible for Study:   Both
Criteria

Study is closed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Generex Biotechnology Corp.
ClinicalTrials.gov 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.:
diabetes
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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014