| Trial ID: | L6837 |
| Source ID: | NCT01013571
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Self Titration With Apidra to Reach Target Study (START)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin glargine|DRUG: Apidra (insulin glulisine)
|
| Outcome Measures: |
Primary: Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia, at week 36 (end of study) | Secondary: Change in HbA1c, FG, and 7-point glucose profile, from Week 12 (randomization) to Week 24 and Week 36|Change in weight, from Week 12 to Week 24 and to Week 36|Incidence of hypoglycemia, Week 12 , Week 24 and Week 36|Treatment satisfaction (DTSQ for patient ), from Week 12 to Week 36|Adherence with the patient-managed monitoring algorithm, Week 12 , Week 24 and Week 36
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
493
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-10
|
| Completion Date: |
2012-01
|
| Results First Posted: |
|
| Last Update Posted: |
2012-03-21
|
| Locations: |
Sanofi-Aventis Administrative Office, Laval, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01013571
|
