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

Diabetes Clinical Trial

Official title:

Comparison of Pharmacodynamics and Pharmacokinetics of the Two Fast-acting Insulin Analogs Insulin Glulisine and Insulin Aspart in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969592
• Other study ID #: 49-0361-GluAsp
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2009
• Last updated: September 1, 2009
• Start date: November 2007
• Est. completion date: June 2008

Study information

• Verified date: September 2009
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH	Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fractional and total glucose infusion rates		0-1 hours, 0-2 hours, and time to 10% of GIRmax	No
Secondary	fractional and total insulin areas under the curve (AUC)		0-1 hours, 0-2 hours, 0-10 hours	No