Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin
- Conditions
- Diabetes Mellitus
- Interventions
- Drug: Generex Oral-lyn™Drug: Regular human insulin
- Registration Number
- NCT00668850
- Lead Sponsor
- Generex Biotechnology Corp.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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;
- 8.5% (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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 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 2 Regular human insulin Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.
- Primary Outcome Measures
Name Time Method 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 change in HbA1c from the Day 0 (V3) to Day 180 (V9) of Treatment Phase.
- Secondary Outcome Measures
Name Time Method To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System 26 week
Trial Locations
- Locations (74)
Coastal Biomedical Research Inc. at Santa Monica
🇺🇸2001 Santa Monica Blvd Suite 390W, California, United States
The Center for Diabetes & Endocrine Care at Hollywood
🇺🇸1150 N. 35th Ave Suite 590, Florida, United States
Physicians Research Group at Indianapolis
🇺🇸7400 North Shadeland Ave, Indiana, United States
MODEL Clinical Research at Baltimore
🇺🇸6535 North Charles Street Suite 400N, Maryland, United States
Grunberger Diabetes Institute at Bloomfield Hills
🇺🇸43494 Woodward Ave Suite 208, Michigan, United States
Beth Israel Medical Center, Geral J. Friedman Diabetes Institute at New York
🇺🇸317 East 17th Street Room 7F05 8th Floor, New York, United States
Multiple Health Research, LLC. at Arlington
🇺🇸501 Rita Lane Suite 113, Texas, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸5323 Harry Hines Blvd, Texas, United States
University Multiprofile Hospital for Active Treatment "Aleksandrovska"
🇧🇬1 St. Georgi Sofiysky St, Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment at Varna
🇧🇬1 Hristo Smirnensky St, Bulgaria
Scroll for more (64 remaining)Coastal Biomedical Research Inc. at Santa Monica🇺🇸2001 Santa Monica Blvd Suite 390W, California, United States