Type 2 diabetes
Conditions
Interventions
Product Name: Insulin in Dextran Matrix
Product Code: Not applicable
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061680
Current Sponsor code: Humulin Regular
Co
Sponsors
BOWS Pharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects with Type 2 diabetes who were diagnosed for a minimum of 6 months, age 30-65 years. 2. Subjects on a stable dose of metformin for at least two months with a total daily dose of = 2600 mg/day. 3. Subjects demonstrating an insulin resistance value (IR) higher than 3 based on the HOMA-2 model (University of Oxford, 2004) at Screening 2. 4. Hemoglobin A1c =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of significant coronary disease or renal failure 2. Other significant medical problems that would preclude participation in a clinical trial 3. Participation in a clinical trial within the prior 3 months 4. History of GI surgery or known GI motility disorders. 5. History of a serious infection, including but not limited to hepatitis, pneumonia, or pyelonephritis, or have been hospitalized or received intravenous antibiotics for an infection, during the previous two months. 6. A chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (bronchiectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), open skin wound, or ulcer. 7. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine (other than diabetes), pulmonary, cardiac, neurologic, or cerebral disease, or any other condition which increases risk of participation in this trial in the opinion of the investigator. 8. Currently known malignancy or a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised more than one year ago with no evidence of recurrence. 9. History of polyps in the gastrointestinal tract 10. Known to have had a substance abuse (drug or alcohol) problem within the previous 5 years 11. Unable to undergo venipunctures for study purposes because of poor tolerability or lack of easy access. 12. Engaging in any strenuous exercise (such as running or weight lifting or playing any team sports such as soccer for 48 hours prior to admission to the inpatient unit and no strenuous exercise will be permitted for the duration of the study (applies to both part 1 and part 2). 13. Donation or loss of 400ml blood or more within 3 months prior to the first dose. 14. Donation of plasma within 7 days prior to the first dose. 15. Difficulty in swallowing capsules. 16. A recent adult history of clinically significant allergic reaction to any drug. 17. Any other medical condition that, in the opinion of the investigator, disqualifies the subject. 18. Female subject with positive pregnancy test at screening, Day -1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety, tolerance and PD profile (i.e. pharmacodynamic parameters for glucose and insulin) of single doses of peroral insulin in patients with Type 2 diabetes;Secondary Objective: To establish the dose(s) when administered in a multi-dose fashion that lowers plasma glucose levels versus placebo in patients with Type 2 diabetes;Primary end point(s): The end-point is capillary blood glucose decrease | — |
Countries
Sweden
Outcome results
None listed