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

NCT ID: NCT00969592

Last Updated: 2009-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-06-30

Brief Summary

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.

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

insulin glulisine, insulin aspart

insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp

Group Type: ACTIVE_COMPARATOR

insulin glulisine, insulin aspart

Intervention Type: DRUG

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

insulin aspart, insulin glulisine

insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp

Group Type: ACTIVE_COMPARATOR

insulin aspart, insulin glulisine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Apidra; NovoRapid; NovoRapid; Apidra

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Profil Institut für Stoffwechselforschung GmbH

Principal Investigators

Sabine Arnolds, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

49-0361-GluAsp

Identifier Type: -

Identifier Source: org_study_id