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

2014-08-27 03:19:10 | BioPortfolio

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.

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 2 Diabetes

Intervention

Oral insulin, regular human insulin

Location

Profil Institut für Stoffwechselforschung GmbH
Neuss
Germany
41460

Status

Completed

Source

Profil Institut für Stoffwechselforschung GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:10-0400

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Medical and Biotech [MESH] Definitions

Regular insulin preparations that contain the HUMAN insulin peptide sequence.

Regular insulin preparations that contain the SUS SCROFA insulin peptide sequence.

A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

An insulin preparation that is designed to provide immediate and long term glycemic control in a single dosage. Biphasic insulin typically contains a mixture of REGULAR INSULIN or SHORT-ACTING INSULIN combined with a LONG-ACTING INSULIN.

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