Clinical Trial Details
| Trial ID: | L7138 |
| Source ID: | NCT00225277 |
| Associated Drug: | Pioglitazone |
| Title: | Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus |
| Acronym: | PERISCOPE |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00225277/results |
| Conditions: | Diabetes Mellitus |
| Interventions: | DRUG: Pioglitazone|DRUG: Glimepiride |
| Outcome Measures: | Primary: Nominal Change From Baseline in Percent Atheroma Volume, The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued., Baseline and Final Visit (up to 72 weeks) | Secondary: Nominal Change From Baseline in Normalized Total Atheroma Volume, The nominal change in normalized total atheroma volume as measured by the average of plaque areas for all slices of anatomically comparable segments of the target coronary artery multiplied by the mean number of matched slices in the population. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued., Baseline and Final Visit (up to 72 weeks)|Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events, Due to low event rates, number of subjects experiencing any of the composite endpoint A cardiovascular events is being reported instead of time to first occurrence. Endpoint A conditions listed in Limitations and Caveats section., Up to 72 weeks|Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events, Due to low event rates, number of subjects experiencing any of the composite endpoint B cardiovascular events is being reported instead of time to first occurrence. Endpoint B conditions listed in Limitations and Caveats section., Up to 72 weeks|Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events, Due to low event rates, number of subjects experiencing any of the composite endpoint C cardiovascular events is being reported instead of time to first occurrence. Endpoint C conditions listed in Limitations and Caveats section., Up to 72 weeks | Other: Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee, The incidence of cardiovascular events and composite endpoints occurring within 30 days of last dose as adjudicated by the Clinical Endpoint Committee. Abbreviations: PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure., Up to 72 weeks |
| Sponsor/Collaborators: | Sponsor: Takeda |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 547 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2003-07 |
| Completion Date: | 2007-10 |
| Results First Posted: | 2009-06-10 |
| Last Update Posted: | 2012-02-28 |
| Locations: | Birmingham, Alabama, United States|Phoenix, Arizona, United States|Huntington Beach, California, United States|Los Angeles, California, United States|Sacramento, California, United States|San Diego, California, United States|Torrance, California, United States|Bridgeport, Connecticut, United States|Farmington, Connecticut, United States|Washington, District of Columbia, United States|Bay Pines, Florida, United States|Jacksonville, Florida, United States|Decatur, Georgia, United States|Boise, Idaho, United States|Chicago, Illinois, United States|Edgewood, Kentucky, United States|Lexington, Kentucky, United States|Louisville, Kentucky, United States|New Orleans, Louisiana, United States|Bangor, Maine, United States|Baltimore, Maryland, United States|Detroit, Michigan, United States|Flint, Michigan, United States|Kalamazoo, Michigan, United States|Petoskey, Michigan, United States|Pontiac, Michigan, United States|Royal Oak, Michigan, United States|Ypsilanti, Michigan, United States|Duluth, Minnesota, United States|Minneapolis, Minnesota, United States|St. Cloud, Minnesota, United States|Columbia, Missouri, United States|Camden, New Jersey, United States|Albany, New York, United States|Bronx, New York, United States|Mineola, New York, United States|New York, New York, United States|Rochester, New York, United States|Troy, New York, United States|West Islip, New York, United States|Williamsville, New York, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Cleveland, Ohio, United States|Columbus, Ohio, United States|Westlake, Ohio, United States|Oklahoma City, Oklahoma, United States|Tulsa, Oklahoma, United States|Abington, Pennsylvania, United States|Bryn Mawr, Pennsylvania, United States|Hershey, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|Providence, Rhode Island, United States|Greenville, South Carolina, United States|Memphis, Tennessee, United States|Oak Ridge, Tennessee, United States|Amarillo, Texas, United States|Houston, Texas, United States|Lubbock, Texas, United States|San Antonio, Texas, United States|Charlottesville, Virginia, United States|Norfolk, Virginia, United States|Richmond, Virginia, United States|Everett, Washington, United States|Green Bay, Wisconsin, United States|Ciudad de Buenos Aires, Argentina|Cordoba, Argentina|Quilmes, Argentina|Edmonton, Alberta, Canada|Vancouver, British Columbia, Canada|Victoria, British Columbia, Canada|Winnepeg, Manitoba, Canada|Saint John, New Brunswick, Canada|London, Ontario, Canada|Ottawa, Ontario, Canada|Montreal, Quebec, Canada|Sainte Foy, Quebec, Canada|Saskatoon, Saskatchewan, Canada|Santiago, Chile |
| URL: | https://clinicaltrials.gov/show/NCT00225277 |
