| Trial ID: | L3589 |
| Source ID: | NCT00770640
|
| Associated Drug: |
Pioglitazone And Insulin
|
| Title: |
Efficacy of Pioglitazone and Insulin in Treating Subjects With Type 2 Diabetes Mellitus and Renal Failure.
|
| Acronym: |
PIOren
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Pioglitazone and insulin|DRUG: Insulin
|
| Outcome Measures: |
Primary: Change of total daily Insulin Dose., Week 24 or Final Visit. | Secondary: Individual insulin doses to assess the number of patients with insulin reduction of greater than or equal to 30%., Weeks 12 and 24 or Final Visit.|Change from Baseline in Glycosylated Hemoglobin., Weeks 12 and 24 or Final Visit.|Change from Baseline in Glucose., Weeks 12 and 24 or Final Visit.|Change from Baseline in Insulin., Weeks 12 and 24 or Final Visit.|Change from Baseline in C-peptide., Weeks 12 and 24 or Final Visit.|Change from Baseline in Intact Proinsulin., Weeks 12 and 24 or Final Visit.|Change from Baseline in Adiponectin., Weeks 12 and 24 or Final Visit.|Change from Baseline in Angiotensin., Weeks 12 and 24 or Final Visit.|Change from Baseline in Relaxin., Weeks 12 and 24 or Final Visit.|Change from Baseline in fetuin A., Weeks 12 and 24 or Final Visit.|Change from Baseline in Carbonyl Protein., Weeks 12 and 24 or Final Visit.|Change from Baseline in Myeloperoxidase., Weeks 12 and 24 or Final Visit.|Change from Baseline in Matrix-Gla Protein., Weeks 12 and 24 or Final Visit.|Change from Baseline in High Sensitivity C-reactive Protein., Weeks 12 and 24 or Final Visit.|Change from Baseline in Cholesterol., Weeks 12 and 24 or Final Visit.|Change from Baseline in High-Density Lipoprotein., Weeks 12 and 24 or Final Visit.|Change from Baseline in Low-Density Lipoprotein., Weeks 12 and 24 or Final Visit.|Change from Baseline in Oxidized Low-Density Lipoprotein., Weeks 12 and 24 or Final Visit.|Change from Baseline in Triglycerides., Weeks 12 and 24 or Final Visit.|Change from Baseline in Matrix Metalloproteinase -9., Weeks 12 and 24 or Final Visit.|Change from Baseline in Monocyte Chemoattractant Protein -1., Weeks 12 and 24 or Final Visit.|Change from Baseline in E-selectin., Weeks 12 and 24 or Final Visit.|Pioglitazone in serum., Week 12.|Change from Baseline in intact Parathyroid Hormone., Weeks 12 and 24 or Final Visit.
|
| Sponsor/Collaborators: |
Sponsor: Takeda
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-08
|
| Completion Date: |
2010-06
|
| Results First Posted: |
|
| Last Update Posted: |
2010-09-01
|
| Locations: |
Schwetzingen, Baden-Württemberg, Germany|Wiesbaden, Hessen, Germany|Bottrop, Nordrhein-Westfalen, Germany|Düsseldorf, Nordrhein-Westfalen, Germany|Lüdenscheid, Nordrhein-Westfalen, Germany|Solingen, Nordrhein-Westfalen, Germany|Alzey, Rheinland-Pfalz, Germany|Ingelheim, Rheinland-Pfalz, Germany|Mainz, Rheinland-Pfalz, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00770640
|
