Status:
COMPLETED
Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers
Lead Sponsor:
Profil Institut für Stoffwechselforschung GmbH
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
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 glulisin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00969592
Start Date
November 1 2007
End Date
June 1 2008
Last Update
September 2 2009
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, D-41460