Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | April 24, 2008 | ||||||||||||
Last Updated Date | June 6, 2011 | ||||||||||||
Start Date ICMJE | April 2008 | ||||||||||||
Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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 [ Time Frame: change in HbA1c from the Day 0 (V3) to Day 180 (V9) of Treatment Phase. ] [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00668850 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System [ Time Frame: 26 week ] [ Designated as safety issue: Yes ] | ||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin | ||||||||||||
Official Title ICMJE | 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 | 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. |
||||||||||||
Detailed Description | This is a 26 week open-label, randomized, multi-center, active comparator study to compare oral spray insulin (Generex Oral-lyn™) with regular human insulin therapy as measured by HbA1c, and number of hypoglycaemic episodes in type-1 diabetes mellitus subject. All subjects will be on BID NPH intermediate acting insulin therapy. If subject is using long acting insulin (Glargine, Detemir, etc.), he/she must be switched to NPH intermediate acting insulin. If on insulin analogue (Novolog, Lispro, Aspart, Aphidra, Glulisine, or any other analogue available in the subject's geographical area), the subject must be switched to regular human insulin 3 times a day. |
||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 3 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||||||
Condition ICMJE | Diabetes Mellitus | ||||||||||||
Intervention ICMJE |
|
||||||||||||
Study Arm (s) |
|
||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
Estimated Enrollment ICMJE | 500 | ||||||||||||
Estimated Completion Date | September 2011 | ||||||||||||
Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
Gender | Both | ||||||||||||
Ages | 18 Years to 75 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Location Countries ICMJE | United States, Bulgaria, Canada, Ecuador, Poland, Puerto Rico, Romania, Russian Federation, Ukraine | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00668850 | ||||||||||||
Other Study ID Numbers ICMJE | GEN-084-OL | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
Responsible Party | George E. Markus, Generex Biotechnology Corp. | ||||||||||||
Study Sponsor ICMJE | Generex Biotechnology Corp. | ||||||||||||
Collaborators ICMJE |
|
||||||||||||
Investigators ICMJE |
|
||||||||||||
Information Provided By | Generex Biotechnology Corp. | ||||||||||||
Verification Date | June 2011 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |