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)

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: Insulin Glargine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Patrick SINNASSAMY, MD, Study Director, Affiliation: Sanofi

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)

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: April 2002
Last updated: August 30, 2010