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A Two Part Study of Peroral Insulin in Type 2 Diabetes

NCT00990444 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-10-05

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Insulin in Dextran Matrix

Fixed dose capsule with 100 IU of insulin in dextran matrix. Investigational drug or placebo are administered in conjunction with food intake on a background of metformin.

Sponsors & Collaborators

  • Bows Pharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Nabil Al-Tawil, M.D.; Ph.D. · Karolinska Trial Alliance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990444 on ClinicalTrials.gov