Type II Diabetes
Conditions
Interventions
Product Name: Capsulin 150iu
Product Code: DTY001
Pharmaceutical Form: Capsule*
INN or Proposed INN: human insulin (rDNA)
Concentration
Sponsors
Diabetology Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or Female. Aged between 18-65 years (inclusive). A BMI of 18-35. Signed informed consent. A confirmed medical history of Type II 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. 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) no 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 medicinal product including vaccines. History or evidence of drug abuse 1 year prior to enrolment. Participation in a clinical study if an investigational product within 3 months prior to the start of the study. History or suspicon of inability to comply with the clinical study protocol. Immunodefiency or clinically autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety of the formulation. To measue the effects of oral insulin (Capsulin) on glucose control. To compare 150U and 300U formulations of Capsulin. ; Secondary Objective: To confirm the kinetics of oral insulin (Capsulin). To measure the bioavailabilty of Capsulin. To study the effects of 10 days with 300U Capsulin on metabolic control. ;Primary end point(s): Glucose infusion rate over the 6 hour study period GIR AUC (0-6h) | — |
Countries
United Kingdom
Outcome results
None listed