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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
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 18, 2006
    Last Updated
    August 30, 2010
    Sponsor
    Sanofi
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    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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