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

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Generex Biotechnology Corp.
• Collaborators: ACM Pivotal Global Central Laboratory; eResearch Technology, Inc.; Hoffmann-La Roche; Nextrials, Inc.; OSMOS Clinical Research, Inc; PSI Pharma Support Intl
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• 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)- 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 Criteria:

• 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