| Trial ID: | L4469 |
| Source ID: | NCT01212913
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)
|
| Acronym: |
B to B
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: INSULIN GLARGINE|DRUG: INSULIN GLULISINE|DRUG: Insulin aspart
|
| Outcome Measures: |
Primary: Change in hemoglobin A1c level (HbA1c), At 6 months of treatment | Secondary: Rate of hypoglycemic events (total, severe, nocturnal), from baseline to the study endpoint (over 6 months of treatment)|Proportion of patients with HbA1c < 7%, from baseline to the study endpoint (over 6 months of treatment)|Change in body weight, from baseline to the study endpoint (over 6 months of treatment)|Reactive Oxidative Stress (ROS) level changes, from baseline to the study endpoint (over 6 months of treatment)|Change in Quality of Life, from baseline to the study endpoint (over 6 months of treatment)|Continuous Glucose Monitoring System (CGMS) data, at baseline, 3 and 6 months
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
161
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-08
|
| Completion Date: |
2012-05
|
| Results First Posted: |
|
| Last Update Posted: |
2013-07-08
|
| Locations: |
Administrative Office, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01212913
|
