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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)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00399724
First received: November 14, 2006
Last updated: August 30, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin glargine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Estimated Enrollment: 7376
Study Start Date: March 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399724

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

Publications:

Additional 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
Study First Received: November 14, 2006
Last Updated: August 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 21, 2013