Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT00969592
First received: August 31, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.


Condition Intervention Phase
Diabetes
Drug: insulin glulisine, insulin aspart
Drug: insulin aspart, insulin glulisine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Comparison of Pharmacodynamics and Pharmacokinetics of the Two Fast-acting Insulin Analogs Insulin Glulisine and Insulin Aspart in Healthy Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • fractional and total glucose infusion rates [ Time Frame: 0-1 hours, 0-2 hours, and time to 10% of GIRmax ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fractional and total insulin areas under the curve (AUC) [ Time Frame: 0-1 hours, 0-2 hours, 0-10 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2007
Study Completion Date: June 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: insulin glulisine, insulin aspart
insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp
Drug: insulin glulisine, insulin aspart
single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during second euglycemic glucose clamp
Other Names:
  • Apidra
  • NovoRapid
Active Comparator: insulin aspart, insulin glulisine
insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp
Drug: insulin aspart, insulin glulisine
single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during second euglycemic glucose clamp
Other Names:
  • NovoRapid
  • Apidra

Detailed Description:

In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. This was the first clinical study realizing a head-to-head comparison between these two insulin analogs.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overtly healthy males or females (Women: contraception, Pearl Index <1%)
  • Between the ages of 18 and 65 years
  • Body Mass Index of <= 27 kg/m²
  • Safety lab within reference range
  • Normal blood pressure and heart rate
  • Sufficient venous access
  • Written informed consent approved by the Ethical Review Board
  • HbA1c and fasting plasma glucose in the normal range

Exclusion Criteria:

  • Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees
  • Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval
  • Known allergies to insulin or related compounds
  • Regular treatment with any drug, both over-the-counter or prescribed
  • an abnormality in the 12-lead ECG increasing the risk for participation
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Significant active neuropsychiatric disease
  • Regular use of drugs of abuse and or positive findings on urinary drug screening
  • Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen
  • Evidence of hepatitis B and/or positive hepatitis C antibody
  • Evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Women with a positive pregnancy test or breastfeeding women
  • Blood donation more than 500 mL within the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969592

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, D-41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Sanofi
Investigators
Principal Investigator: Sabine Arnolds, MD Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
  More Information

No publications provided

Responsible Party: Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT00969592     History of Changes
Other Study ID Numbers: 49-0361-GluAsp
Study First Received: August 31, 2009
Last Updated: September 1, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014