A Two Part Study of Peroral Insulin in Type 2 Diabetes
Status:
Suspended
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Insulin is normally not bioavailable when taken through the oral route, as degradation of the
molecule may occur both in the ventricle and in the intestine. Oral administration with
uptake from the lesser intestine would offer major advantages if made possible. It would
offer a simple non-injection method to administer insulin in connection with a meal and
absorbed insulin would enter the blood stream and mimic the natural distribution in the body
with a first pass through the liver. The sponsor of this study has developed a novel oral
insulin formulation that is based on a proprietary dextran matrix. The investigational drug
is a capsule containing 100 IU of human insulin in dextran matrix.
The primary objective of this study is to establish the safety, tolerance and PD profile
(i.e. pharmacodynamic parameters for glucose and insulin) of peroral insulin in dextran
matrix in patients with type 2 diabetes.
The phase I/II study protocol consists of two parts; part 1 (dose finding) and part 2 (dose
verification). In study part 1 single escalating doses of oral insulin or placebo is given to
the test subjects. Capillary blood glucose is used to assess the insulin effect.
Subsequently, in study part 2, the investigational drug will be administered 3 times daily on
6 consecutive days. The starting dose of part 2 will be the lowest effective dose found in
study part 1. Dose escalation will be done in increments of 100 IU. The total number of
subjects will be 32 (for part 1 and 2 combined).