Type 2 diabetes MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: Capsulin 150IU
Product Code: DTY001
Pharmaceutical Form: Capsule*
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061680
Sponsors
Diabetology Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety of Capsulin To measure the effects of oral insulin on glucose control To compare 150IU and 300IU doses of Capsulin and control ; Secondary Objective: To confirm the kinetics of oral insulin To establish baseline glucose control ;Primary end point(s): To measure the change in glucose infusion rate (GIR) in response to Capsulin | — |
Countries
United Kingdom
Outcome results
None listed