Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin

Status unconfirmed · Phase 3

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00668850

Run by

Generex Biotechnology Corp.

People needed

500

Starts

2008-04-01

Expected to finish

2011-09-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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 Saint Georgi Sofiysky Saint, Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment at Varna — 1 Hristo Smirnensky Saint, Bulgaria
• Multiprofile Hospital for Active Treatment at Stara Zagora — 11 Armeyska Saint, Bulgaria
• University Multiprofile Hospital for Active Treatment at Plovdiv — 15A Vassil Aprilov Blvd, Bulgaria
• Multiprofile Hospital for Active Treatment at Ruse — 2 Nezavisimost Saint, Bulgaria
• University Multiprofile Hospital for Active Treatment at Pleven — 8A Georgi Kotchev Saint, Bulgaria
• The Bailey Clinic at Red Deer — #108 3947 50A Avenue, Alberta, Canada
• Calgary Metabolic Education & Research Centre at Calgary — #23, 4411-16th Avenue Northwest, Alberta, Canada
• West Edmonton Diabetes Centre — 10230 142 Saint Northwest # 25, Edmonton, Alberta, Canada
• Instituto de Endocrinologia IEMYR — Avenida La Coruña Nº 6337 Y San Ignacio, Quito, Ecuador
• Bydgoszcz Diabetology and Endocrinology Center at Bydgoszcz — Ul. Baczynskiego 17, Poland
• OSTEOMED Medical Center at Warszawa — Ul. Bialobrzeska 40A, Poland
• Chair and Department of Internal Medicine and Diabetology, Voivodship Brodnowski Hospital at Warszawa — Ul. Kondratowicza 8, Poland
• Diabetology Clinic for Adults, NZOZ Elblag Diabetology Center — Ul. Krolewiecka 146, Poland
• TeMeD - Clinical Trials at Rzeszow — Ul. Mazowiecka 56, Poland
• Provincial Centre of Diabetology and Metabolic Diseases, M.Pirogow Provincial Specialist Hospital at Lodz — Ul. Nowa 30/32, Poland
• Silesia Osteoporosis Center at Katowice — Ul. Opolska 11/3, Poland
• Coastal Biomedical Research Inc. at Santa Monica — 2001 Santa Monica Blvd Suite 390W, California, United States

Full record on ClinicalTrials.gov

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