NCT00948493

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™.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

First QC Date

July 27, 2009

Last Update Submit

March 18, 2013

Conditions

Type 1 Diabetes MellitusType 2 Diabetes Mellitus

Keywords

diabetesinsulin therapy

Interventions

Buccal insulin sprayDRUG

Oral insulin spray absorbed in buccal mucosa

Also known as: Generex Oral-lynTM (oral, buccal insulin spray)

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Study is closed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Last Updated

March 20, 2013

Record last verified: 2013-03