| Trial ID: | L4130 |
| Source ID: | NCT00399724
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
|
| Acronym: |
AT-LANTUS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin glargine
|
| Outcome Measures: |
Primary: Incidence of severe hypoglycaemia | Secondary: Incidence of any hypoglycaemia|Incidence of symptomatic hypoglycaemia|Incidence of nocturnal hypoglycaemia|Incidence of asymptomatic hypoglycaemia|Adjusted mean change in Hb1Ac (%)|Adjusted mean change in fasting blood glucose (FBG) (mg/dl)|Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)|Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)|% of subjects at v12 with Hb1Ac < or = 6.5 %|% of subjects at v12 with Hb1Ac < or = 7.0 %|% of subjects at v12 with FBG < or = 100 mg/dl|Weight change (kg)|Change in insulin glargine dose v2 - v12 (IU)|Safety data|Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
7376
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-03
|
| Completion Date: |
2003-08
|
| Results First Posted: |
|
| Last Update Posted: |
2010-08-31
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00399724
|
