| Trial ID: | L5478 |
| Source ID: | NCT00552370
|
| Associated Drug: |
Lantus®
|
| Title: |
Glycemic Optimization Treatment Study
|
| Acronym: |
GOT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Lantus®
|
| Outcome Measures: |
Primary: To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG)., From the start to the end of the study | Secondary: To compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms., From the start to the end of the study
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
5062
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-03
|
| Completion Date: |
2005-03
|
| Results First Posted: |
|
| Last Update Posted: |
2009-07-21
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00552370
|