Trial record 2 of 3 for:    generex

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00948493
Expanded Access Status : No longer available
First Posted : July 29, 2009
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
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™.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: Buccal insulin spray

Study Type : 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Study is closed

No Contacts or Locations Provided

Responsible Party: Generex Biotechnology Corp. Identifier: NCT00948493     History of Changes
Other Study ID Numbers: GEN-100-OL
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Generex Biotechnology Corp.:
insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs