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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Generex Biotechnology Corp..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: April 24, 2008
Last updated: June 6, 2011
Last verified: June 2011

April 24, 2008
June 6, 2011
April 2008
August 2011   (final data collection date for primary outcome 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668850 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • 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
    Other Name: buccal Insulin spray
  • Drug: Regular human insulin
    Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.
    Other Name: insulin
  • Experimental: 1
    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
    Intervention: Drug: Generex Oral-lyn™
  • Active Comparator: 2
    Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.
    Intervention: Drug: Regular human insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Canada,   Ecuador,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Ukraine
 
NCT00668850
GEN-084-OL
No
George E. Markus, Generex Biotechnology Corp.
Generex Biotechnology Corp.
  • OSMOS Clinical Research, Inc
  • PSI Pharma Support Intl
  • Nextrials, Inc.
  • eResearch Technology, Inc.
  • Hoffmann-La Roche
  • ACM Pivotal Global Central Laboratory
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
Generex Biotechnology Corp.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP