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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)

NCT00390728 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2346

Last updated 2010-08-31

No results posted yet for this study

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)

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin Glargine

Sponsors & Collaborators

Principal Investigators

  • Patrick SINNASSAMY, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2003-08-31
Completion
2003-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00390728 on ClinicalTrials.gov