Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399724
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2006-11-14
Brief Title:
A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicentre Multinational Randomised Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus Insulin Glargine Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes Safety and Satisfaction in Subjects With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2010-08
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:
AT-LANTUS
Brief Summary:
Primary objective
To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia
Secondary objectives
To determine for each treatment algorithm the incidence of asymptomatic symptomatic and nocturnal hypoglycaemia
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment
To obtain safety data on the use of insulin glargine in each treatment algorithm
To measure change in subject weight and insulin dose between baseline and end of treatment
To determine subject quality of life and treatment satisfaction sub-study
To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia
Secondary objectives
To determine for each treatment algorithm the incidence of asymptomatic symptomatic and nocturnal hypoglycaemia
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment
To obtain safety data on the use of insulin glargine in each treatment algorithm
To measure change in subject weight and insulin dose between baseline and end of treatment
To determine subject quality of life and treatment satisfaction sub-study
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