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) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00390728

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 IV

MedlinePlus related topics: Depression Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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

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-Aventis

Investigators

Study Director:

Patrick SINNASSAMY, MD

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	HOE901_3505
Study First Received:	October 18, 2006
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00390728 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Quality of Life
Diabetes Mellitus Type 1
Hypoglycemia

Insulin
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Hypoglycemia

Insulin
Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009