Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial) (AT-LANTUS)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion criteria:
- Subjects with type 1 diabetes mellitus who require a basal (long-acting) insulin for the control of hyperglycemia, with HbA1c values > 7.0% and < 12 %, and a body mass index (BMI) < 40 kg/m2.
Sites / Locations
Outcomes
Primary Outcome Measures
Main study: Frequency of severe hypoglycaemia
Sub-study: The fear of hypoglycaemia as measured by the Hypoglycaemia Fear Survey questionnaire (HFS-98) assessed at baseline, 3 months and study end point or upon withdrawal of the subject from the study.
Secondary Outcome Measures
Main study: HbA1c
Incidence of nocturnal, symptomatic and asymptomatic hypoglycaemia
Self monitored blood glucose
Change in subject weight
Changes in doses of insulin
Changes in treatment satisfaction
Safety assessment
Quality of Life (QoL)using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Sub-study:Quality of Life tools assessed at baseline, 3 months and at study end point or upon withdrawal of the subject
Quality of Life - EQ-5D
Hospital Anxiety and Depression Scale (HADS)
Adverse events correlating with Quality of Life tools and hypoglycaemic events
Medications for diabetes
HbA1c
Weight and height (BMI)
Proportion of patients reaching HbA1c target as per participation with the Prescription Plan
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00390728
Brief Title
Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)
Acronym
AT-LANTUS
Official Title
A Phase IIIb/IV, 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
Primary objective:
AT.LANTUS main study*
To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemia.(*Target Number of patients for the main study:2346)
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 diabetes.(**Target Number of patients for the Sub-study: 250)
Secondary objectives:
AT.LANTUS 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2346 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Primary Outcome Measure Information:
Title
Main study: Frequency of severe hypoglycaemia
Title
Sub-study: The fear of hypoglycaemia as measured by the Hypoglycaemia Fear Survey questionnaire (HFS-98) assessed at baseline, 3 months and study end point or upon withdrawal of the subject from the study.
Secondary Outcome Measure Information:
Title
Main study: HbA1c
Title
Incidence of nocturnal, symptomatic and asymptomatic hypoglycaemia
Title
Self monitored blood glucose
Title
Change in subject weight
Title
Changes in doses of insulin
Title
Changes in treatment satisfaction
Title
Safety assessment
Title
Quality of Life (QoL)using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Title
Sub-study:Quality of Life tools assessed at baseline, 3 months and at study end point or upon withdrawal of the subject
Title
Quality of Life - EQ-5D
Title
Hospital Anxiety and Depression Scale (HADS)
Title
Adverse events correlating with Quality of Life tools and hypoglycaemic events
Title
Medications for diabetes
Title
HbA1c
Title
Weight and height (BMI)
Title
Proportion of patients reaching HbA1c target as per participation with the Prescription Plan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Subjects with type 1 diabetes mellitus who require a basal (long-acting) insulin for the control of hyperglycemia, with HbA1c values > 7.0% and < 12 %, and a body mass index (BMI) < 40 kg/m2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick SINNASSAMY, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)
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