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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,346
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.
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
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