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)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin Glargine

Study type

Interventional

Funder types

Industry

Identifiers

HOE901_3505

Details and patient eligibility

About

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)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.