Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272077
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2006-01-02
Brief Title:
Insulin Glargine in Type 2 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Pilot Study on Glycaemic Variability in Type 2 Diabetes Mellitus Patients With Basal Insulin and Fixed Combo Oral Antidiabetic Treatment
Status:
COMPLETED
Status Verified Date:
2009-12
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 evaluate in explorative manner the fasting blood glucose FBG coefficient of variability CVcalculated on SMBG values SMBG Self-Monitoring of Blood Glucose
Secondary objectives
The secondary objectives are the assessment of changes in glycaemic control HbA1C frequency of hypoglycaemias changes in weight final insulin dose changes in lipid parameters changes in urinary albumin-to-creatinine ratio profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age gender race tobacco use diabetes complications initial HbA1C initial weight duration of diabetes mellitus general education and diabetes education
To evaluate in explorative manner the fasting blood glucose FBG coefficient of variability CVcalculated on SMBG values SMBG Self-Monitoring of Blood Glucose
Secondary objectives
The secondary objectives are the assessment of changes in glycaemic control HbA1C frequency of hypoglycaemias changes in weight final insulin dose changes in lipid parameters changes in urinary albumin-to-creatinine ratio profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age gender race tobacco use diabetes complications initial HbA1C initial weight duration of diabetes mellitus general education and diabetes education
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 2004-002730-19 | None | None | None |