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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin glulisine; Insulin, Globin Zinc; Insulin, Long-Acting

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