Clinical Trial Details
| Trial ID: | L3234 |
| Source ID: | NCT01434186 |
| Associated Drug: | Placebo Matching With Saxagliptin |
| Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01434186/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Placebo matching with Saxagliptin|DRUG: Metformin IR|DRUG: Metformin XR|DRUG: Saxagliptin |
| Outcome Measures: | Primary: Mean Change in HbA1c From Baseline to Week 16, 16 week short term treatment period | |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE3 |
| Enrollment: | 32 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-05 |
| Completion Date: | 2016-04 |
| Results First Posted: | 2017-04-18 |
| Last Update Posted: | 2017-04-18 |
| Locations: | Research Site, Los Angeles, California, United States|Research Site, Tallahassee, Florida, United States|Research Site, Dearborn, Michigan, United States|Research Site, St. Paul, Minnesota, United States|Research Site, Mineola, New York, United States|Research Site, Cleveland, Ohio, United States|Research Site, Memphis, Tennessee, United States|Research Site, Namur, Belgium|Research Site, Calgary, Alberta, Canada|Research Site, Bangalore, India|Research Site, Aguascalientes, Mexico|Research Site, Meridas, Mexico|Research Site, Monterrey, Mexico|Research Site, Veracruz, Mexico|Research Site, Taichung, Taiwan|Research Site, Leicester, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT01434186 |
