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

NCT ID: NCT00948493

Last Updated: 2013-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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™.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Interventions

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Buccal insulin spray

Oral insulin spray absorbed in buccal mucosa

Intervention Type DRUG

Other Intervention Names

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Generex Oral-lynTM (oral, buccal insulin spray)

Eligibility Criteria

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Inclusion Criteria

Study is closed
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Generex Biotechnology Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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GEN-100-OL

Identifier Type: -

Identifier Source: org_study_id

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