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

September 22, 2009 updated by: Profil Institut für Stoffwechselforschung GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subjects between the ages of 35 and 70 years, inclusive, with Type 2 diabetes mellitus as defined by the ADA criteria for more than one year
  • Subjects must have Body Mass Index (BMI) < 36 kg/m²
  • Stable glycemic control (HbA1C <11%)
  • Subjects must be off all oral hypoglycemic agents 24 hours prior to each study dosing day and off any investigational drug for at least 4 weeks
  • Subjects must refrain from strenuous physical activity beginning 72 hours prior to admission and through the duration of the study
  • Subjects must be willing and able to be confined to the Clinical Research Unit as required by the protocol
  • Subjects must be willing and able to provide written informed consent

Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
  • Subjects with gastroparesis, orthostatic hypotension and hypoglycemia unawareness (autonomic neuropathy).
  • Subjects with "brittle" diabetes or predisposition to severe hypoglycemia, e.g., 2 or more serious hypoglycemic episodes (requiring another's assistance) within the past year, or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months.
  • Evidence of significant active hematological disease and/or cumulative blood donation of 1 unit (500 mL) or more including blood drawn during clinical trials in the last 3 months
  • Positive hepatitis B (hepatitis B surface antigen) and/or hepatitis C (hepatitis C antibody) serology
  • Positive HIV serology
  • Evidence of significant active neuropsychiatric disease
  • Known allergy to human insulin excipients contained in these products
  • Regular alcohol intake greater than 28 units*/week (male), or 21 units/week (female), or subjects unwilling to stop alcohol for the duration of the study (* 1 unit = 8 g ethanol, ¼ liter of beer or 1 glass wine or 1 measure of spirits)
  • Intake of any drug which in the evaluation of the investigator may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilisation or recovery from hypoglycaemia.
  • Treatment with s.c. insulin injections.
  • Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted
  • Have any other condition (including drug abuse, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, precludes the patient from following and completing the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Humulin R (100 U/mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose Infusion Rate (GIR)
Time Frame: For each treatment continuously from 6 hours before dosing until 6 hours after dosing
For each treatment continuously from 6 hours before dosing until 6 hours after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma insulin concentration
Time Frame: For each treatment at regular times from 6 hours before dosing until 6 hours after dosing
For each treatment at regular times from 6 hours before dosing until 6 hours after dosing
Plasma C-Peptide
Time Frame: For each treatment at regular times from 6 hours before dosing until 6 hours after dosing
For each treatment at regular times from 6 hours before dosing until 6 hours after dosing
Adverse Events
Time Frame: For each treatment before and after end of clamp
For each treatment before and after end of clamp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Collaborators

Emisphere Technologies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (ACTUAL)

November 1, 2001

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (ESTIMATE)

September 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2009

Last Update Submitted That Met QC Criteria

September 22, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 175A-C-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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