Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174668
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2005-09-09
Brief Title:
Insulin Glulisine in Diabetes Mellitus Type 2
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
52-week Open Randomized Multinational Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-injection Conventional Insulin Therapy
Status:
COMPLETED
Status Verified Date:
2009-09
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:
GINGER
Brief Summary:
Primary objective
The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c HbA1c from baseline to endpoint
Secondary objectives
Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose BG values fasting pre-postprandial ppBG nocturnal mean daily fasting plasma glucose daily BG profiles BG and HbA1c response rates predefined hypoglycemic events adverse events change of late diabetes complications weight body-mass-index course of total daily insulin dose and adjustment blood lipid profile microalbuminuria standard lab and quality of lifetreatment satisfaction
The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c HbA1c from baseline to endpoint
Secondary objectives
Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose BG values fasting pre-postprandial ppBG nocturnal mean daily fasting plasma glucose daily BG profiles BG and HbA1c response rates predefined hypoglycemic events adverse events change of late diabetes complications weight body-mass-index course of total daily insulin dose and adjustment blood lipid profile microalbuminuria standard lab and quality of lifetreatment satisfaction
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT 2004-001287-49 | None | None | None |