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ClinicalTrials.gov record
Not listed Phase 3 Interventional

Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin

ClinicalTrials.gov ID: NCT00668850

Public ClinicalTrials.gov record NCT00668850. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 10:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 26-Week, Open-Label, Randomized, Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin In Subjects With Type-1 Diabetes Mellitus

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To compare the efficacy of Generex Oral-lyn™ RapidMist™ System and standard regular human insulin therapy as measured by HbA1c, in type-1 diabetes mellitus subjects on BID NPH intermediate acting insulin therapy.

Study identification

NCT ID
NCT00668850
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Generex Biotechnology Corp.
Industry
Enrollment
500 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2008
Primary completion
Jul 31, 2011
Completion
Aug 31, 2011
Last update posted
Jun 7, 2011

2008 – 2011

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
Coastal Biomedical Research Inc. at Santa Monica 2001 Santa Monica Blvd Suite 390W California 90404
The Center for Diabetes & Endocrine Care at Hollywood 1150 N. 35th Ave Suite 590 Florida 33021
Physicians Research Group at Indianapolis 7400 North Shadeland Ave Indiana
MODEL Clinical Research at Baltimore 6535 North Charles Street Suite 400N Maryland 21204
Grunberger Diabetes Institute at Bloomfield Hills 43494 Woodward Ave Suite 208 Michigan 48302
Beth Israel Medical Center, Geral J. Friedman Diabetes Institute at New York 317 East 17th Street Room 7F05 8th Floor New York 10003
Multiple Health Research, LLC. at Arlington 501 Rita Lane Suite 113 Texas 76014
University of Texas Southwestern Medical Center at Dallas 5323 Harry Hines Blvd Texas 75390-8858

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 66 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00668850, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 7, 2011 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00668850 live on ClinicalTrials.gov.

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