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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)

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00390728
Acronym
AT-LANTUS
Enrollment
2346
Registered
2006-10-20
Start date
2002-04-30
Completion date
2003-08-31
Last updated
2010-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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)

Interventions

DRUGInsulin Glargine

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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
Main study: HbA1c
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
Quality of Life - EQ-5D
Incidence of nocturnal, symptomatic and asymptomatic hypoglycaemia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026