Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310297
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2006-03-02
Brief Title:
Insulin Glulisine in Type 2 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open Label Two-arm Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day in obese subjects with type 2 diabetes
Secondary objectives
To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes injected subcutaneously before three standard meals during a 12-hour day
The safety of insulin glulisine the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide non-esterified fatty acid triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed
To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day in obese subjects with type 2 diabetes
Secondary objectives
To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes injected subcutaneously before three standard meals during a 12-hour day
The safety of insulin glulisine the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide non-esterified fatty acid triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None