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Insulin

1 for Diabetes

Phase 3
Waitlist Available
Led By Philip Raskin, MD
Research Sponsored by Generex Biotechnology Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in hba1c from the day 0 (v3) to day 180 (v9) of treatment phase.
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in hba1c from the day 0 (v3) to day 180 (v9) of treatment phase.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in hba1c from the day 0 (v3) to day 180 (v9) of treatment phase. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
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
Group II: 2Active Control1 Intervention
Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.

Find a Location

Who is running the clinical trial?

Nextrials, Inc.Industry Sponsor
1 Previous Clinical Trials
eResearch Technology, Inc.Industry Sponsor
3 Previous Clinical Trials
812 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,431 Previous Clinical Trials
1,089,568 Total Patients Enrolled
4 Trials studying Diabetes
292 Patients Enrolled for Diabetes

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin
2008. "Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00668850.
All > Cte
~29 spots leftby Apr 2025
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