| Trial ID: | L4363 |
| Source ID: | NCT00135941
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: insulin glargine|DRUG: insulin glulisine
|
| Outcome Measures: |
Primary: To compare improvements from baseline in patient reported outcomes (quality of life, treatment satisfaction) when aggressively treated with insulin glargine plus rapid acting insulin glulisine vs treatment with Premix insulin, 24 months | Secondary: change in A1c (baseline to week 24), reported hypo events (throughout the trials), correlation between patient reported outcomes and glucose variability as measured by CGMS (baseline, week 8 and week 20)., 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
582
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-08
|
| Completion Date: |
2007-09
|
| Results First Posted: |
|
| Last Update Posted: |
2009-06-04
|
| Locations: |
Advanced Healthcare, Milwaukee, Wisconsin, 53209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00135941
|
