Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390728
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2006-10-18
Brief Title:
Insulin Glargine in Type I Diabetes Mellitus Main Study ATLANTUS A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar Sub-study HALTHypoglycaemia Avoidance With Lantus Trial
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase IIIbIV Multinational Multicentre 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 1 Diabetes Mellitus HALT Sub-study Multicentre Open Clinical Trial to Assess the Effect of Insulin Glargine on Symptomatic Hypoglycaemia Fear of Hypoglycaemia and Quality of Life in Patients With Type 1 Diabetes
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
ATLANTUS main study
To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemiaTarget Number of patients for the main study2346
HALT Sub-study
To test the hypothesis that titration regimens involving insulin glargine are associated with changes in the rate of symptomatic hypoglycaemic episodes together with changes in Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I diabetesTarget Number of patients for the Sub-study 250
Secondary objectives
ATLANTUS main study
To determine
the incidence of symptomatic asymptomatic and nocturnal hypoglycaemia with each treatment regimen
the difference in glycemic control as measured by HbA1c and fasting blood glucose with each treatment regimen
the difference in glycemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment
the safety on the use of insulin glargine in each treatment algorithm
the change in subject weight with each treatment regimen
the change in insulin doses with each treatment regimen
the change in Diabetes Treatment Satisfaction Diabetes Treatment Satisfaction Questionnaire sub-study only with each treatment regimen
HALT Sub-study baseline to study end
To estimate the relationship between change in HbA1c and incidence of hypoglycaemia
To examine the effect of insulin glargine on Quality of Life EQ-5D in relation to incidence of hypoglycaemia
To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale HADS in relation to the incidence of hypoglycaemia
To examine the use of the Prescription Plan versus standard management no Prescription Plan
ATLANTUS main study
To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemiaTarget Number of patients for the main study2346
HALT Sub-study
To test the hypothesis that titration regimens involving insulin glargine are associated with changes in the rate of symptomatic hypoglycaemic episodes together with changes in Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I diabetesTarget Number of patients for the Sub-study 250
Secondary objectives
ATLANTUS main study
To determine
the incidence of symptomatic asymptomatic and nocturnal hypoglycaemia with each treatment regimen
the difference in glycemic control as measured by HbA1c and fasting blood glucose with each treatment regimen
the difference in glycemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment
the safety on the use of insulin glargine in each treatment algorithm
the change in subject weight with each treatment regimen
the change in insulin doses with each treatment regimen
the change in Diabetes Treatment Satisfaction Diabetes Treatment Satisfaction Questionnaire sub-study only with each treatment regimen
HALT Sub-study baseline to study end
To estimate the relationship between change in HbA1c and incidence of hypoglycaemia
To examine the effect of insulin glargine on Quality of Life EQ-5D in relation to incidence of hypoglycaemia
To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale HADS in relation to the incidence of hypoglycaemia
To examine the use of the Prescription Plan versus standard management no Prescription Plan
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