Diabetes Mellitus
Conditions
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.
Interventions
DRUGInsulin Glulisine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
: * Normal HbA1c * Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.
Exclusion criteria
: * Systemic concomitant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the serum insulin glulisine concentration and insulin lispro concentration | During the Study Conduct |
Secondary
| Measure | Time frame |
|---|---|
| To measure blood glucose | During the study conduct |
| 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 |
Outcome results
None listed