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

This study has been completed.
Sponsor:
Collaborator:
Emisphere Technologies, Inc.
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT00982254
First received: September 14, 2009
Last updated: September 22, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Oral insulin
Drug: regular human insulin
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: October 2001
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982254

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Emisphere Technologies, Inc.
Investigators
Principal Investigator: Tim Heise, MD Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
  More Information

No publications provided by Profil Institut für Stoffwechselforschung GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tim Heise, MD, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
ClinicalTrials.gov Identifier: NCT00982254     History of Changes
Other Study ID Numbers: 175A-C-02
Study First Received: September 14, 2009
Last Updated: September 22, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
Type 2 Diabetes
Oral Insulin
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014