Insulin Glulisine in Healthy Lean and Obese Subjects
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|ClinicalTrials.gov Identifier: NCT00311077|
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : December 7, 2009
- 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™.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: Insulin Glulisine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Crossover Assignment|
|Official Title:||Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||October 2004|
- To evaluate the serum insulin glulisine concentration and insulin lispro concentration [ Time Frame: During the Study Conduct ]
- To measure blood glucose [ Time Frame: During the study conduct ]
- To measure glucose infusion rate [ Time Frame: During the study conduct ]
- To measure the serum C-peptide [ Time Frame: During the study conduct ]
- Adverse events collection [ Time Frame: from the inform consent signed up to the end of the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311077
|Study Director:||Valérie Pilorget, MD||Sanofi|