Clinical Trial Details
| Trial ID: | L2402 |
| Source ID: | NCT02551874 |
| Associated Drug: | Saxagliptin, Onglyza |
| Title: | A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02551874/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Saxagliptin, Onglyza|DRUG: Dapagliflozin, Farxiga|DRUG: Glargine insulin|DRUG: Metformin |
| Outcome Measures: | Primary: Mean Change From Baseline in HbA1c at Week 24, To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment., Baseline and Week 24 | Secondary: Mean Change From Baseline in Total Body Weight at Week 24, To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment, Baseline and Week 24|Percentage of Subjects With Confirmed Hypoglycaemia at Week 24, Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L), Baseline and Week 24|Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24, To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment., Baseline and Week 24|Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24, To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment., Baseline and Week 24|Change From Baseline in the Mean Value of 24-hour Glucose at Week 2, Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment., Baseline and Week 2 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 650 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2015-10-20 |
| Completion Date: | 2017-11-10 |
| Results First Posted: | 2018-09-18 |
| Last Update Posted: | 2018-12-11 |
| Locations: | Research Site, Anaheim, California, 92801, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Miami, Florida, 33144, United States|Research Site, Miami, Florida, 33155, United States|Research Site, Saint Petersburg, Florida, 33709, United States|Research Site, Norcross, Georgia, 30071, United States|Research Site, Chicago, Illinois, 60612, United States|Research Site, Lexington, Kentucky, 40502, United States|Research Site, Quincy, Massachusetts, 02169, United States|Research Site, Beavercreek, Ohio, 45432, United States|Research Site, Norman, Oklahoma, 73069, United States|Research Site, Barto, Pennsylvania, 19504, United States|Research Site, Columbia, South Carolina, 29204, United States|Research Site, Bristol, Tennessee, 37620, United States|Research Site, Kingsport, Tennessee, 37660, United States|Research Site, Houston, Texas, 77004, United States|Research Site, Mesquite, Texas, 74194, United States|Research Site, San Antonio, Texas, 78230, United States|Research Site, San Antonio, Texas, 78258, United States|Research Site, Bountiful, Utah, 84010, United States|Research Site, Karlovy Vary, 360 01, Czechia|Research Site, Olomouc, 772 00, Czechia|Research Site, Koebenhavn, 2400, Denmark|Research Site, Budapest, 1032, Hungary|Research Site, Budapest, 1097, Hungary|Research Site, Budapest, 1171, Hungary|Research Site, Guadalajara, 44670, Mexico|Research Site, Mexico, 03800, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, Zapopan, Jalisco, 45200, Mexico|Research Site, Lodz, 92-003, Poland|Research Site, Nowy Duninow, 09-505, Poland|Research Site, Sochaczew, 96-500, Poland|Research Site, Craiova, 200349, Romania|Research Site, Ploiesti, 100018, Romania|Research Site, Timisoara, 300125, Romania|Research Site, Timișoara, 300456, Romania|Research Site, Lenasia, 1827, South Africa|Research Site, La Coruña, 15006, Spain|Research Site, Uddevalla, 451 80, Sweden |
| URL: | https://clinicaltrials.gov/show/NCT02551874 |
