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)

Diabetes Mellitus, Type 1 Clinical Trial

— AT-LANTUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390728
• Other study ID #: HOE901_3505
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2006
• Last updated: August 30, 2010
• Start date: April 2002
• Est. completion date: August 2003

Study information

• Verified date: August 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2346
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• Insulin Glargine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main study: Frequency of severe hypoglycaemia
Primary	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	Main study: HbA1c
Secondary	Incidence of nocturnal, symptomatic and asymptomatic hypoglycaemia
Secondary	Self monitored blood glucose
Secondary	Change in subject weight
Secondary	Changes in doses of insulin
Secondary	Changes in treatment satisfaction
Secondary	Safety assessment
Secondary	Quality of Life (QoL)using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Secondary	Sub-study:Quality of Life tools assessed at baseline, 3 months and at study end point or upon withdrawal of the subject
Secondary	Quality of Life - EQ-5D
Secondary	Hospital Anxiety and Depression Scale (HADS)
Secondary	Adverse events correlating with Quality of Life tools and hypoglycaemic events
Secondary	Medications for diabetes
Secondary	HbA1c
Secondary	Weight and height (BMI)
Secondary	Proportion of patients reaching HbA1c target as per participation with the Prescription Plan