| Trial ID: | L2043 |
| Source ID: | NCT00488527
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
DOMME Dose Optimization Multicentric Mexican Evaluation
|
| Acronym: |
DOMME
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin glargine
|
| Outcome Measures: |
Primary: Change in the initial vs. final values of HbA1c, 9 months|Number of severe hypoglycemia, 9 months | Secondary: - Change in the fasting glucose values with each visit, 9 months|- Incidences of symptomatic and asymptomatic nocturnal hypoglycemia - Evaluations of safety with regards to the use of insulin glargine, recording the adverse events, excluding hypoglycemia - Abnormal laboratory results, 9 months|- Change in body weight initial visit vs. final visit, 9 months
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
371
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-04
|
| Completion Date: |
2008-12
|
| Results First Posted: |
|
| Last Update Posted: |
2010-09-13
|
| Locations: |
Sanofi-Aventis, Mexico, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT00488527
|
