Insulin Glulisine in Healthy Lean and Obese Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin glulisine; Insulin, Globin Zinc

Criteria

Inclusion criteria :

• Normal HbA1c

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

Exclusion criteria :

• Systemic concomitant medication