Insulin Glulisine in Healthy Lean and Obese Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00311077
• Lead Sponsor: Sanofi

Brief Summary

Primary objective

* To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™.

Secondary objective

* To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2004-10
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-05
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
To evaluate the serum insulin glulisine concentration and insulin lispro concentration	During the Study Conduct

Secondary Outcome Measures

Name	Time	Method
To measure glucose infusion rate	During the study conduct
To measure the serum C-peptide	During the study conduct
Adverse events collection	from the inform consent signed up to the end of the study
To measure blood glucose	During the study conduct