Clinical trial NCT00390728: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-20
Enrollment: 2346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility 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.

Primary outcomes:
measure: Main study: Frequency of severe hypoglycaemia
measure: 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 outcomes:
measure: Main study: HbA1c
measure: Incidence of nocturnal, symptomatic and asymptomatic hypoglycaemia
measure: Self monitored blood glucose
measure: Change in subject weight
measure: Changes in doses of insulin
measure: Changes in treatment satisfaction
measure: Safety assessment
measure: Quality of Life (QoL)using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
measure: Sub-study:Quality of Life tools assessed at baseline, 3 months and at study end point or upon withdrawal of the subject
measure: Quality of Life - EQ-5D
measure: Hospital Anxiety and Depression Scale (HADS)
measure: Adverse events correlating with Quality of Life tools and hypoglycaemic events
measure: Medications for diabetes
measure: HbA1c
measure: Weight and height (BMI)
measure: Proportion of patients reaching HbA1c target as per participation with the Prescription Plan
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Patrick SINNASSAMY, MD
role: STUDY_DIRECTOR
References: