| Trial ID: | L6185 |
| Source ID: | NCT00384215
|
| Associated Drug: |
Insulin Glargine [Rdna Origin] Injection
|
| Title: |
Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin glargine [rDNA origin] injection
|
| Outcome Measures: |
Primary: To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin. | Secondary: Compare occurrence of hypoglycemia|Compare change in body weight|Compare change in FPG|Compare change in serum lipid profile|Compare percentage of subjects achieving HbA1c levels </= 7%|Compare the time until an HbA1c </= 7% is achieved|Compare change in HRQOL|Compare cost of therapy for hyperglycemia treatment
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
352
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-12
|
| Completion Date: |
2005-02
|
| Results First Posted: |
|
| Last Update Posted: |
2011-01-11
|
| Locations: |
Sanofi-Aventis, Bridgewater, New Jersey, 08807, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00384215
|
