A Phase Ib, Single Centre, Open Label, Parallel-Group, Controlled Study of Effects on Metabolic Control of an Oral Insulin Formulation in a Type 2 Diabetic Population. - 24 hour oral insulin

Diabetology Ltd0 个研究点目标入组 6 人开始时间: 2007年1月5日最近更新: 2019年11月25日

适应症

试验速览

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•Subjects will be considered for entry into the study if they are:
•Males or females.
•Aged between 18-70 years (inclusive).
•Have a body mass index (BMI) of 18-35kg/m2.
•Signed informed consent.
•Have a confirmed medical history of type 2 diabetes
•Without major organ pathology (e.g. cardiac, immunological, psychiatric, endocrine or neurological disorders, cancer or other wasting diseases – (adequately treated actinic keratosis, or basal cell carcinoma [BCC], or carcinoma in situ [CIS] of the cervix are permitted).
•A fasting blood glucose of less than 10 mmol/L
•Taking stable appropriate oral antidiabetic medication for 3 months
•Have completed study DBTY_000/Capsulin/1Mar more than 8 weeks before the start of 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

•Presence of any clinically significant medical condition as determined by the Investigator.
•Medically significant hypersensitivity or idiosyncratic reaction related to any medical product including vaccines.
•History or evidence of drug abuse 1 year prior to enrolment.
•Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
•History or suspicion of inability to co-operate adequately.
•Immunodeficiency or clinically autoimmune disease.
•Positive breath alcohol and drug screen for drugs of abuse (methadone, cocaine, amphetamines, cannabinoids, and barbiturates).
•Positive history of human immunodeficiency virus (HIV), and/or hepatitis B and/or hepatitis C.
•Clinically relevant abnormal findings on routine physical examination.
•Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatinine, potassium, liver function tests (LFT), (>3 x upper limit of normal); absolute neutrophil count, platelet count, white blood cell count, electrolytes and blood haemoglobin.
•Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator.

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