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)

August 30, 2010 updated by: Sanofi

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2346

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
HbA1c
Hospital Anxiety and Depression Scale (HADS)
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
Adverse events correlating with Quality of Life tools and hypoglycaemic events
Medications for diabetes
Weight and height (BMI)
Proportion of patients reaching HbA1c target as per participation with the Prescription Plan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Patrick Sinnassamy, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

October 18, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 20, 2006

Study Record Updates

Last Update Posted (Estimate)

August 31, 2010

Last Update Submitted That Met QC Criteria

August 30, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_3505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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