Clinical Trial Details
| Trial ID: | L2384 |
| Source ID: | NCT00772174 |
| Associated Drug: | Pioglitazone And Metformin |
| Title: | Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes |
| Acronym: | PRISMA |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus |
| Interventions: | DRUG: Pioglitazone and Metformin|DRUG: Metformin |
| Outcome Measures: | Primary: Increase in High-Density Lipoprotein cholesterol levels., Final Visit. | Secondary: The change from Baseline in Metabolic Syndrome, as defined by the International Diabetes Federation (aggregate waist circumference, fasting plasma glucose, triglycerides and high-density lipoprotein cholesterol)., Weeks: 8 and 24.|The change from Baseline in Metabolic Syndrome, as defined by the International Diabetes Federation (blood pressure)., At all Visits.|The change from Baseline in Individual Metabolic Parameters (insulin sensitivity and beta-cell function, inflammatory cytokines, adipokines, endothelial functionality)., Weeks: 8 and 24.|Adverse Events., At all Visits.|The change from Baseline in Laboratory Parameters (hematology, chemistry and urinalysis)., Weeks: 8 and 24. |
| Sponsor/Collaborators: | Sponsor: Takeda |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 418 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-01 |
| Completion Date: | 2008-02 |
| Results First Posted: | |
| Last Update Posted: | 2010-07-05 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00772174 |
