Clinical Trial Details
| Trial ID: | L5889 |
| Source ID: | NCT00960076 |
| Associated Drug: | Saxagliptin |
| Title: | An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes |
| Acronym: | SCORE |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00960076/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Saxagliptin|DRUG: Metformin XR|DRUG: Metformin XR |
| Outcome Measures: | Primary: Change in HbA1c Level From Baseline to Week 18 (LOCF), Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value., Baseline to week 18 | Secondary: Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF), Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value., Baseline to week 18|Change in FPG From Baseline to Week 18 (LOCF), Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value., Baseline to week 18|Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1), Percent of subjects achieving therapeutic response (HbA1c \<7.0%) at Week 18 (LOCF) (Randomized analysis set), Week 18 (LOCF) |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 282 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2009-08 |
| Completion Date: | 2010-10 |
| Results First Posted: | 2011-09-27 |
| Last Update Posted: | 2011-09-27 |
| Locations: | Research Site, Jonesboro, Arkansas, United States|Research Site, Anaheim, California, United States|Research Site, Fountain Valley, California, United States|Research Site, Los Angeles, California, United States|Research Site, Pasadena, California, United States|Research Site, Sacramento, California, United States|Research Site, Gainesville, Florida, United States|Research Site, Wellington, Florida, United States|Research Site, Chicago, Illinois, United States|Research Site, Springfield, Illinois, United States|Research Site, Indianapolis, Indiana, United States|Research Site, St Louis, Missouri, United States|Research Site, Salisbury, North Carolina, United States|Research Site, Wilmington, North Carolina, United States|Research Site, Winston-salem, North Carolina, United States|Research Site, Columbus, Ohio, United States|Research Site, Marion, Ohio, United States|Research Site, Simpsonville, South Carolina, United States|Research Site, Bristol, Tennessee, United States|Research Site, Alexandria, Virginia, United States|Research Site, Burke, Virginia, United States|Research Site, Manassas, Virginia, United States|Research Site, Barranquilla, Atlantico, Colombia|Research Site, Barranquilla, Colombia|Research Site, Bogota, Colombia|Research Site, Curridabat, San Jose, Costa Rica|Research Site, Los Yoses, San Jose, Costa Rica|Research Site, Heredia, Costa Rica|Research Site, Mexico, D.f., Mexico|Research Site, Guadalajara, Jalisco, Mexico|Research Site, Zapopan, Jalisco, Mexico|Research Site, Cuernavaca, Morelos, Mexico|Research Site, Durango, Mexico|Research Site, Queretaro, Mexico|Research Site, Lima, Peru |
| URL: | https://clinicaltrials.gov/show/NCT00960076 |
