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

NCT ID: NCT00982254

Last Updated: 2009-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Insulin

oral insulin capsule formulation

Group Type: EXPERIMENTAL

Oral insulin

Intervention Type: DRUG

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.

Subcutaneous Insulin

Subcutaneous injection of regular human insulin

Group Type: ACTIVE_COMPARATOR

regular human insulin

Intervention Type: DRUG

subcutaneous injection of 15 U regular human insulin; single dose administration on one separate dosing visit.

Interventions

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.

Intervention Type: DRUG

regular human insulin

subcutaneous injection of 15 U regular human insulin; single dose administration on one separate dosing visit.

Intervention Type: DRUG

Other Intervention Names

Humulin R (100 U/mL)

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Emisphere Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Principal Investigators

Tim Heise, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

References

Kapitza C, Zijlstra E, Heinemann L, Castelli MC, Riley G, Heise T. Oral insulin: a comparison with subcutaneous regular human insulin in patients with type 2 diabetes. Diabetes Care. 2010 Jun;33(6):1288-90. doi: 10.2337/dc09-1807. Epub 2010 Feb 25.

Reference Type: DERIVED

PMID: 20185734 (View on PubMed)

Other Identifiers

175A-C-02

Identifier Type: -

Identifier Source: org_study_id