| Trial ID: | L6391 |
| Source ID: | NCT00390728
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
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)
|
| Acronym: |
AT-LANTUS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Insulin Glargine
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
2346
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-04
|
| Completion Date: |
2003-08
|
| Results First Posted: |
|
| Last Update Posted: |
2010-08-31
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00390728
|
