Status:
UNKNOWN
Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin
Lead Sponsor:
Generex Biotechnology Corp.
Collaborating Sponsors:
OSMOS Clinical Research, Inc
PSI Pharma Support Intl
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 insu...
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...
Eligibility Criteria
Inclusion
- Be male or female between the ages 18 to 75 years
- Type 1 diabetes mellitus patients (according to ADA and/or WHO classification) who have \>1 year history of type 1 DM and are currently managed with daily insulin injections totalling 0.3 to 0.8 IU/kg of body weight;
- Current physical examination, vital signs and ECG at screening that reveals no clinically significant abnormalities;
- Have a body mass index (BMI) \<27;
- 5% (inclusively)\<Have a glycosylated haemoglobulin HbA1c
- Willing and able to follow the American Diabetes Association diet guidelines for type 1 diabetes; be able to commit to perform home blood glucose monitoring and record values as well as hypoglycemic events
- Willing to give written informed consent prior to admission into the study.
Exclusion
- Have a significant active asthma or suspected abnormalities of buccal mucosa; cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, hematological, or auto-immune disease (other than auto-immune thyroid disease); history of athopy or drugs allergy
- Have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension);
- Have hypoglycemia unawareness;
- Have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months;
- Have a blood pressure in excess of 160/100 mmHg at the Screening visit;
- Have had any acute illness within the 2 weeks prior to screening;
- Have a history of drug or alcohol abuse that in the opinion of the Investigator would interfere with participation in the protocol
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00668850
Start Date
April 1 2008
End Date
September 1 2011
Last Update
June 8 2011
Active Locations (74)
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1
Coastal Biomedical Research Inc. at Santa Monica
2001 Santa Monica Blvd Suite 390W, California, United States, 90404
2
The Center for Diabetes & Endocrine Care at Hollywood
1150 N. 35th Ave Suite 590, Florida, United States, 33021
3
Physicians Research Group at Indianapolis
7400 North Shadeland Ave, Indiana, United States
4
MODEL Clinical Research at Baltimore
6535 North Charles Street Suite 400N, Maryland, United States, 21204