type 1 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Product Name: Generex Oral-lyn™
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: Rec Human Insulin
CAS Number: 11061-68-0
Other descriptive name: IND number 57, 144 Oralin (oral insulin form
Sponsors
Generex Biotechnology Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must satisfy all of the following inclusion criteria to participate in the study: 1.Be male or female between the ages 18 to 75 years 2.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; 3.Current physical examination, vital signs and ECG at screening that reveals no clinically significant abnormalities; 4.Have a body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following exclusion criteria: 1.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; 2.Have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension); 3.Have hypoglycemia unawareness; 4.Have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months; 5.Have a blood pressure in excess of 160/100 mmHg at the Screening visit; 6.Have had any acute illness within the 2 weeks prior to screening; 7.Have a history of drug or alcohol abuse that in the opinion of the investigator nwould interfere with participation in the protocol 8. Have received any investigationa drug within 30 days prior to screening 9.Have positive pregnancy test, or is a breast feeding woman , or a woman not using an adequate method of contraception; 10.Have an oral lesion(s) and/or active disease involving the oral cavity;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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. ;Primary end point(s): The primary efficacy parameter is comparison of longer-term glycemic control as reflected by change in HbA1c from the day 0 to day 180 of Treatment Phase;Secondary Objective: -To evaluate the glycemic response in two different treatment groups, evaluating the blood glucose levels as described in section 9.7 -To evaluate the number and severity of hypoglycemic episodes -To evaluate insulin antibody titers -To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System Determine the percentage of patients unable to use either injectable or buccal forms of insulin during recruitment and thereafter | — |
Countries
Bulgaria
Outcome results
None listed