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A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus (AT-LANTUS)

Primary Purpose

Diabetes Mellitus, Type 2

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 2

Eligibility Criteria

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

Inclusion criteria:

  • Subjects with Type 2 Diabetes Mellitus,
  • Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months,
  • Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
  • HbA1c values > 7.0% and < 12 %,
  • BMI < 40 kg/m².

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence of severe hypoglycaemia

    Secondary Outcome Measures

    Incidence of any hypoglycaemia
    Incidence of symptomatic hypoglycaemia
    Incidence of nocturnal hypoglycaemia
    Incidence of asymptomatic hypoglycaemia
    Adjusted mean change in Hb1Ac (%)
    Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
    Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
    Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
    % of subjects at v12 with Hb1Ac < or = 6.5 %
    % of subjects at v12 with Hb1Ac < or = 7.0 %
    % of subjects at v12 with FBG < or = 100 mg/dl
    Weight change (kg)
    Change in insulin glargine dose v2 - v12 (IU)
    Safety data
    Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire

    Full Information

    First Posted
    November 14, 2006
    Last Updated
    August 30, 2010
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00399724
    Brief Title
    A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
    Acronym
    AT-LANTUS
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 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: 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    7376 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Insulin glargine
    Primary Outcome Measure Information:
    Title
    Incidence of severe hypoglycaemia
    Secondary Outcome Measure Information:
    Title
    Incidence of any hypoglycaemia
    Title
    Incidence of symptomatic hypoglycaemia
    Title
    Incidence of nocturnal hypoglycaemia
    Title
    Incidence of asymptomatic hypoglycaemia
    Title
    Adjusted mean change in Hb1Ac (%)
    Title
    Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
    Title
    Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
    Title
    Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
    Title
    % of subjects at v12 with Hb1Ac < or = 6.5 %
    Title
    % of subjects at v12 with Hb1Ac < or = 7.0 %
    Title
    % of subjects at v12 with FBG < or = 100 mg/dl
    Title
    Weight change (kg)
    Title
    Change in insulin glargine dose v2 - v12 (IU)
    Title
    Safety data
    Title
    Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Subjects with Type 2 Diabetes Mellitus, Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months, Subjects who require a basal long-acting insulin for the control of hyperglycaemia, HbA1c values > 7.0% and < 12 %, BMI < 40 kg/m². The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    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

    Citations:
    PubMed Identifier
    18355327
    Citation
    Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
    Results Reference
    result
    PubMed Identifier
    17980928
    Citation
    Davies M, Sinnassamy P, Storms F, Gomis R; AT.LANTUS Study Group. Insulin glargine-based therapy improves glycemic control in patients with type 2 diabetes sub-optimally controlled on premixed insulin therapies. Diabetes Res Clin Pract. 2008 Feb;79(2):368-75. doi: 10.1016/j.diabres.2007.09.013. Epub 2007 Nov 5.
    Results Reference
    result
    PubMed Identifier
    15920040
    Citation
    Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
    Results Reference
    result
    PubMed Identifier
    20590745
    Citation
    Khunti K, Srinivasan BT, Shutler S, Davies MJ. Effect of insulin glargine on glycaemic control and weight in obese and non-obese people with type 2 diabetes: data from the AT.LANTUS trial. Diabetes Obes Metab. 2010 Aug;12(8):683-8. doi: 10.1111/j.1463-1326.2010.01217.x.
    Results Reference
    derived

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    A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus

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