drugset / Trial / NCT00668850
Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin
Phase 3
Unknown
500 enrolled
Generex Biotechnology Corp.
ACM Pivotal Global Central Laboratory · collabHoffmann-La Roche · collabNextrials, Inc. · collabOSMOS Clinical Research, Inc · collabPSI Pharma Support Intl · collabeResearch Technology, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
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
- Start
- 2008-04
- Primary completion
- 2011-08
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Generex Oral-lyn™ | Unknown | — | Oral |
| Comparator | Insulin | Protein / enzyme biologic | — | — |