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

NCT00668850 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2011-06-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Generex Oral-lyn™

Generex Oral-lyn™ spray in a split-dose fashion (half the dose immediately prior to the meal and half the dose immediately after the meal) + BID NPH insulin AM and PM as pre-randomization dose

DRUG

Regular human insulin

Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.

Sponsors & Collaborators

  • OSMOS Clinical Research, Inc

    collaborator OTHER

  • PSI Pharma Support Intl

    collaborator UNKNOWN

  • Nextrials, Inc.

    collaborator INDUSTRY

  • eResearch Technology, Inc.

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • ACM Pivotal Global Central Laboratory

    collaborator INDUSTRY

  • Generex Biotechnology Corp.

    lead INDUSTRY

Principal Investigators

  • Gerald Bernstein,, MD · Generex Biotechnology Corp.

  • Jaime Davidson, MD · Generex Biotechnology Corp.

  • Philip Raskin, MD · University of Texas, Southwestern Medical Center at Dallas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Ecuador
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Ukraine

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668850 on ClinicalTrials.gov