Insulin Glulisine in Healthy Lean and Obese Subjects

Diabetes Mellitus Clinical Trial

Official title:

Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311077
• Other study ID #: HMR1964A_1502
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2006
• Last updated: December 4, 2009
• Start date: April 2004

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria :

• Normal HbA1c

• Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.

Exclusion criteria :

• Systemic concomitant medication

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin Glulisine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the serum insulin glulisine concentration and insulin lispro concentration		During the Study Conduct	No
Secondary	To measure blood glucose		During the study conduct	No
Secondary	To measure glucose infusion rate		During the study conduct	No
Secondary	To measure the serum C-peptide		During the study conduct	No
Secondary	Adverse events collection		from the inform consent signed up to the end of the study	No