Oral Insulin: A Comparison With Subcutaneous Regular Human Insulin in Patients With Type 2 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparison of the Pharmacodynamic and Pharmacokinetic Properties of Oral Insulin vs. s.c. Regular Insulin in Type 2 Diabetic Patients|
- Glucose Infusion Rate (GIR) [ Time Frame: For each treatment continuously from 6 hours before dosing until 6 hours after dosing ] [ Designated as safety issue: No ]
- Plasma insulin concentration [ Time Frame: For each treatment at regular times from 6 hours before dosing until 6 hours after dosing ] [ Designated as safety issue: No ]
- Plasma C-Peptide [ Time Frame: For each treatment at regular times from 6 hours before dosing until 6 hours after dosing ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: For each treatment before and after end of clamp ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2001|
|Primary Completion Date:||November 2001 (Final data collection date for primary outcome measure)|
Experimental: Oral Insulin
oral insulin capsule formulation
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.
Active Comparator: Subcutaneous Insulin
Subcutaneous injection of regular human insulin
Drug: regular human insulin
subcutaneous injection of 15 U regular human insulin; single dose administration on one separate dosing visit.
Other Name: Humulin R (100 U/mL)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982254
|Profil Institut für Stoffwechselforschung GmbH|
|Neuss, Germany, 41460|
|Principal Investigator:||Tim Heise, MD||Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany|