NCT00982254

Oral Insulin: A Comparison With Subcutaneous Regular Human Insulin in Patients With Type 2 Diabetes

A Comparison of the Pharmacodynamic and Pharmacokinetic Properties of Oral Insulin vs. s.c. Regular Insulin in Type 2 Diabetic Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Profil Institut für Stoffwechselforschung GmbH · Industry
• Sex: Male
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study compared the pharmacokinetic and pharmacodynamic properties of an oral insulin formulation with that of a standard subcutaneous injection of regular human insulin.

Detailed description

This study was a single centre, randomized, 3-period crossover study performed in patients with type 2 diabetes. Patients received single doses of an oral insulin formulation and subcutaneous regular human insulin on separate visits. The primary objective of this study was to compare the pharmacokinetic and pharmacodynamic properties of an oral insulin formulation with that of 15 U subcutaneous injected regular human insulin. Pharmacokinetic and pharmacodynamic parameters including bioavailability and bioefficacy were measured during 6-hour glucose clamp experiments. Study duration: 2 months

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Oral insulin	oral insulin capsule formulation (150 U insulin/200 mg 4-CNAB in one capsule); single dose administration of 300 U insulin (in two capsules) and of 150 U insulin (one capsule) on two separate dosing days.
DRUG	regular human insulin	subcutaneous injection of 15 U regular human insulin; single dose administration on one separate dosing visit.

Timeline

• Start date: 2001-10-01
• Primary completion: 2001-11-01
• First posted: 2009-09-23
• Last updated: 2009-09-23

Locations

1 site across 1 country: Germany