Active Comparator Study of Generex Oral-Lyn™ Spray and Injected Human Insulin - Full Text View

Sponsors and Collaborators:	Generex Biotechnology Corp. OSMOS Clinical Research, Inc PSI Pharma Support Intl Nextrials, Inc. eResearch Technology, Inc. Hoffmann-La Roche ACM Pivotal Global Central Laboratory
Information provided by:	Generex Biotechnology Corp.
ClinicalTrials.gov Identifier:	NCT00668850

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Generex Oral-lyn™ Drug: Regular human insulin	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Generex Biotechnology Corp.:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System [ Time Frame: 26 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	750
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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	Drug: 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: Active Comparator Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.	Drug: Regular human insulin Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)<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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668850

Contacts

Contact: Kirill Soldatov

7-812-320-3855

Kirill.Soldatov@psi-cro.com

Show 76 Study Locations

Sponsors and Collaborators

Generex Biotechnology Corp.

OSMOS Clinical Research, Inc

PSI Pharma Support Intl

Nextrials, Inc.

eResearch Technology, Inc.

Hoffmann-La Roche

ACM Pivotal Global Central Laboratory

Investigators

Study Chair:	Gerald Bernstein,, MD	Generex Biotechnology Corp.
Study Director:	Jaime Davidson, MD	Generex Biotechnology Corp.
Principal Investigator:	Philip Raskin, MD	University of Texas Southwestern Medical Center at Dallas

More Information

Responsible Party:	Generex Biotechnology Corp. ( George E. Markus )
Study ID Numbers:	GEN-084-OL
Study First Received:	April 24, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00668850
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009