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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)

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ClinicalTrials.gov Identifier: NCT00399724
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:

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)

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin glargine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2002
Primary Completion Date : August 2003
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Incidence of severe hypoglycaemia

Secondary Outcome Measures :
  1. Incidence of any hypoglycaemia
  2. Incidence of symptomatic hypoglycaemia
  3. Incidence of nocturnal hypoglycaemia
  4. Incidence of asymptomatic hypoglycaemia
  5. Adjusted mean change in Hb1Ac (%)
  6. Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
  7. Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
  8. Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
  9. % of subjects at v12 with Hb1Ac < or = 6.5 %
  10. % of subjects at v12 with Hb1Ac < or = 7.0 %
  11. % of subjects at v12 with FBG < or = 100 mg/dl
  12. Weight change (kg)
  13. Change in insulin glargine dose v2 - v12 (IU)
  14. Safety data
  15. Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399724


Sponsors and Collaborators
Sanofi
Investigators
Study Director: Patrick Sinnassamy, MD Sanofi
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00399724     History of Changes
Other Study ID Numbers: HOE901_3504
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs