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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)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00390728
First received: October 18, 2006
Last updated: August 30, 2010
Last verified: August 2010
History of Changes
  Purpose

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)

Condition Intervention Phase
Diabetes Mellitus, Type 1
 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 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Estimated Enrollment: 2346
Study Start Date: April 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390728

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

No publications provided

ClinicalTrials.gov Identifier: NCT00390728     History of Changes
Other Study ID Numbers: HOE901_3505
Study First Received: October 18, 2006
Last Updated: August 30, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013