Clinical Trial Details
| Trial ID: | L2562 |
| Source ID: | NCT02419612 |
| Associated Drug: | Saxagliptin |
| Title: | A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02419612/results |
| Conditions: | Diabetes |
| Interventions: | DRUG: Saxagliptin|DRUG: Dapagliflozin|DRUG: Glimepiride|OTHER: Placebo |
| Outcome Measures: | Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52, To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment., Baseline and Week 52 | Secondary: Change From Baseline in Total Body Weight at Week 52, To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment., Baseline and Week 52|Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52, Therapeutic glycemic response was defined as HbA1c \<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c., At Week 52|Change From Baseline in Systolic Blood Pressure (SBP) at Week 52, To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment., Baseline and Week 52|Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period, Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period., Up to Week 52|Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period., Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period., Up to Week 156|Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156, Therapeutic glycemic response was defined as HbA1c \<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c., At Week 156|Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period., Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model., Up to Week 156 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 444 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-08-14 |
| Completion Date: | 2019-09-18 |
| Results First Posted: | 2018-10-19 |
| Last Update Posted: | 2020-06-23 |
| Locations: | Research Site, Birmingham, Alabama, 35211, United States|Research Site, Chandler, Arizona, 85224, United States|Research Site, Tempe, Arizona, 85283, United States|Research Site, Huntington Park, California, 90255, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Sacramento, California, 95823, United States|Research Site, Tarzana, California, 91356, United States|Research Site, Waterbury, Connecticut, 06708, United States|Research Site, Jacksonville, Florida, 32207, United States|Research Site, Jacksonville, Florida, 32277, United States|Research Site, Kissimmee, Florida, 34744, United States|Research Site, Miami, Florida, 33126, United States|Research Site, Miami, Florida, 33174, United States|Research Site, New Port Richey, Florida, 34652, United States|Research Site, Palm Harbor, Florida, 34684, United States|Research Site, Edina, Minnesota, 55435, United States|Research Site, Las Vegas, Nevada, 89128, United States|Research Site, Greer, South Carolina, 29651, United States|Research Site, Bristol, Tennessee, 37620, United States|Research Site, Knoxville, Tennessee, 37912, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Cheb, 350 02, Czechia|Research Site, Hradec Kralove, 503 41, Czechia|Research Site, Krnov, 794 01, Czechia|Research Site, Kromeriz, 767 01, Czechia|Research Site, Nachod, 54701, Czechia|Research Site, Praha 4, 140 00, Czechia|Research Site, Praha 4, 149 00, Czechia|Research Site, Dresden, 01307, Germany|Research Site, Leipzig, 04249, Germany|Research Site, Ajka, 8400, Hungary|Research Site, Balatonfüred, 8230, Hungary|Research Site, Budapest, 1033, Hungary|Research Site, Budapest, 1089, Hungary|Research Site, Budapest, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Eger, 3300, Hungary|Research Site, Gyula, 5700, Hungary|Research Site, Kaposvár, 7400, Hungary|Research Site, Kecskemét, 6000, Hungary|Research Site, Nyíregyháza, 4405, Hungary|Research Site, Zalaegerszeg, 8900, Hungary|Research Site, Aguascalientes, 20230, Mexico|Research Site, Chihuahua, 31237, Mexico|Research Site, Cuautla, 62746, Mexico|Research Site, Guadalajara, 44600, Mexico|Research Site, Guanajuato, 38000, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, Veracruz, 91910, Mexico|Research Site, Białystok, 15-351, Poland|Research Site, Katowice, 40-648, Poland|Research Site, Kraków, 31-156, Poland|Research Site, Kraków, 31-261, Poland|Research Site, Opole, 45-367, Poland|Research Site, Oswiecim, 32-600, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Warszawa, 00-465, Poland|Research Site, Warszawa, 02-507, Poland|Research Site, Wroclaw, 50-349, Poland|Research Site, Łódź, 90-242, Poland|Research Site, Brasov, 500269, Romania|Research Site, Bucuresti, 020045, Romania|Research Site, Bucuresti, 020359, Romania|Research Site, Buzau, 120203, Romania|Research Site, Galati, 800291, Romania|Research Site, Oradea, 410032, Romania|Research Site, Oradea, 410169, Romania|Research Site, Ploiesti, 100163, Romania|Research Site, Ploiesti, 100342, Romania|Research Site, Satu-Mare, 440055, Romania|Research Site, Targu, 540142, Romania|Research Site, Timisoara, 300736, Romania|Research Site, Novosibirsk, 630087, Russian Federation|Research Site, Saint Petersburg, 195257, Russian Federation|Research Site, Smolensk, 214018, Russian Federation|Research Site, St. Petersburg, 190013, Russian Federation|Research Site, St. Petersburg, 194354, Russian Federation|Research Site, St. Petersburg, 196084, Russian Federation|Research Site, St.-Petersburg, 195176, Russian Federation|Research Site, Göteborg, 413 45, Sweden|Research Site, Helsingborg, 25220, Sweden|Research Site, Rättvik, 79530, Sweden|Research Site, Dundee, DD1 9SY, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT02419612 |
