Diabetes Mellitus Clinical Trial
Official title:
A Double-Blind Two Part Placebo-Controlled Study Consisting of a Single Ascending and Multiple-Dose Tolerance Study of Peroral Insulin in Patients With Type 2 Diabetes
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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