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

NCT00982254 | Completed Phase 1

• 1 other identifier: 175A-C-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Oral Insulin; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Glucose Infusion Rate (GIR)

  For each treatment continuously from 6 hours before dosing until 6 hours after dosing

Secondary Outcomes (3)

• Plasma insulin concentration

  For each treatment at regular times from 6 hours before dosing until 6 hours after dosing

• Plasma C-Peptide

  For each treatment at regular times from 6 hours before dosing until 6 hours after dosing

• Adverse Events

  For each treatment before and after end of clamp

Study Arms (2)

Oral Insulin

EXPERIMENTAL

oral insulin capsule formulation

Drug: Oral insulin

Subcutaneous Insulin

ACTIVE COMPARATOR

Subcutaneous injection of regular human insulin

Drug: regular human insulin

Interventions

Oral insulin 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.

Oral Insulin

regular human insulin DRUG

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

Also known as: Humulin R (100 U/mL)

Subcutaneous Insulin

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead
• Emisphere Technologies, Inc.: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• 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.

  PMID: 20185734 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tim Heise, MD

  Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 23, 2009
• Study Start: October 1, 2001
• Primary Completion: November 1, 2001
• Last Updated: September 23, 2009

Record last verified: 2009-09

Locations

DE (1)