| Trial ID: | L5034 |
| Source ID: | NCT00653302
|
| Associated Drug: |
Lantus (Insulin Glargine) + Glucophage (Metformin)
|
| Title: |
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
|
| Acronym: |
GALATEE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Lantus (insulin glargine) + Glucophage (Metformin)
|
| Outcome Measures: |
Primary: % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal)., During the study conduct | Secondary: Determination of the predictive criterion of HbA1c final, During the study conduct|Determination of the predictive criterion of weight variation, During all the study conduct|HbA1c and weight variations (final value - basal value), during the study|AE/SAE evaluation, from the informed consent signed up to the end of the study
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
280
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-04
|
| Completion Date: |
2005-10
|
| Results First Posted: |
|
| Last Update Posted: |
2008-12-03
|
| Locations: |
Sanofi-aventis administrative office, Paris, France
|
| URL: |
https://clinicaltrials.gov/show/NCT00653302
|
