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

Primary Purpose

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Buccal insulin spray
Sponsored by
Generex Biotechnology Corp.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Type 1 Diabetes Mellitus focused on measuring diabetes, insulin therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes
Study is closed

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2009
    Last Updated
    March 18, 2013
    Sponsor
    Generex Biotechnology Corp.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00948493
    Brief Title
    Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Generex Biotechnology Corp.

    4. Oversight

    5. Study Description

    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™.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
    Keywords
    diabetes, insulin therapy

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Buccal insulin spray
    Other Intervention Name(s)
    Generex Oral-lynTM (oral, buccal insulin spray)
    Intervention Description
    Oral insulin spray absorbed in buccal mucosa

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Study is closed

    12. IPD Sharing Statement

    Learn more about this trial

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

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