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 insuli
- Conditions
- Type 2 diabetesMedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
- Registration Number
- EUCTR2006-006251-12-GB
- Lead Sponsor
- Diabetology Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To determine the safety of Capsulin<br> To measure the effects of oral insulin on glucose control<br> To compare 150IU and 300IU doses of Capsulin and control<br> ;<br> Secondary Objective: To confirm the kinetics of oral insulin<br> To establish baseline glucose control<br> ;Primary end point(s): To measure the change in glucose infusion rate (GIR) in response to Capsulin
- Secondary Outcome Measures
Name Time Method