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Completed

NCT Number: NCT00390728

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)

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)

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

Primary outcomes

  1. Main study: Frequency of severe hypoglycaemia

  2. 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 outcomes

  1. Main study: HbA1c

  2. Incidence of nocturnal, symptomatic and asymptomatic hypoglycaemia

  3. Self monitored blood glucose

  4. Change in subject weight

  5. Changes in doses of insulin

  6. Changes in treatment satisfaction

  7. Safety assessment

  8. Quality of Life (QoL)using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

  9. Sub-study:Quality of Life tools assessed at baseline, 3 months and at study end point or upon withdrawal of the subject

  10. Quality of Life - EQ-5D

  11. Hospital Anxiety and Depression Scale (HADS)

  12. Adverse events correlating with Quality of Life tools and hypoglycaemic events

  13. Medications for diabetes

  14. HbA1c

  15. Weight and height (BMI)

  16. Proportion of patients reaching HbA1c target as per participation with the Prescription Plan

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: AT-LANTUS

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 20, 2006
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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