Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments generex oral-lyn™, regular human insulin
Phase phase 3
Sponsor Generex Biotechnology Corp.
Collaborator OSMOS Clinical Research, Inc
Start date April 2008
End date August 2011
Trial size 500 participants
Trial identifier NCT00668850, GEN-084-OL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
generex oral-lyn™ buccal Insulin spray
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
(Active Comparator)
Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.
regular human insulin insulin
Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System
time frame: 26 week

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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)

Additional Information

Official title 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
Principal investigator Philip Raskin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Generex Biotechnology Corp..