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

Generex Biotechnology Corp.0 个研究点目标入组 750 人开始时间: 2008年5月21日最近更新: 2013年10月21日

适应症

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•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) <27;
•5.Have a glycosylated haemoglobulin HbA1c 6.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
•7.Willing to give written informed consent prior to admission into the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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;

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