Clinical Trial Details
| Trial ID: | L6124 |
| Source ID: | NCT01204775 |
| Associated Drug: | Saxagliptin |
| Title: | Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01204775/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Saxagliptin|DRUG: Placebo (Saxagliptin)|DRUG: Metformin IR|DRUG: Placebo (Metformin)|DRUG: Metformin (Active Rescue) |
| Outcome Measures: | Primary: Mean Change in HbA1c From Baseline to Week 16, 16 week short term treatment period | |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE3 |
| Enrollment: | 26 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-06 |
| 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, San Diego, California, United States|Research Site, Hollywood, Florida, United States|Research Site, Tallahassee, Florida, United States|Research Site, Tampa, Florida, United States|Research Site, Dearborn, Michigan, United States|Research Site, Buffalo, New York, United States|Research Site, Memphis, Tennessee, United States|Research Site, Richmond, Virginia, United States|Research Site, Moscow, Russian Federation|Research Site, Novosibirsk, Russian Federation|Research Site, Saint Petersburg, Russian Federation|Research Site, Cape Town, South Africa|Research Site, Pretoria, South Africa|Research Site, Taichung, Taiwan|Research Site, Taipei, Taiwan |
| URL: | https://clinicaltrials.gov/show/NCT01204775 |
