NCT00311077CompletedPhase 1
Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Primary Endpoint
- To evaluate the serum insulin glulisine concentration and insulin lispro concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
To evaluate the serum insulin glulisine concentration and insulin lispro concentration
Time Frame: During the Study Conduct
Secondary Outcomes
- 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)
Investigators
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