Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-25 @ 4:07 PM
Study NCT ID:
NCT00135057
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Insulin Glulisine Administered in a Fixed Bolus Regimen Versus Variable Bolus Regimen Based on Carbohydrate Counting in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: