NCT00969592

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Profil Institut für Stoffwechselforschung GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-12-01
• Completion: 2008-06-01
• First posted: 2009-09-01
• Last updated: 2009-09-02

Locations

1 site across 1 country: Germany