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Clinical Trial Details

Trial ID: L1780
Source ID: NCT01646320
Associated Drug: Dapagliflozin
Title: Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01646320/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Placebo matching with Dapagliflozin|DRUG: Saxagliptin|DRUG: Metformin immediate release (IR)
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24, HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period., From Baseline to Week 24 | Secondary: Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24, Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period, From Baseline to Week 24|Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24, 2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT., From Baseline to Week 24|Adjusted Mean Change From Baseline in Body Weight at Week 24, Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period., From baseline to Week 24|Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]), Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis., From baseline to week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 320
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-09
Completion Date: 2015-02
Results First Posted: 2016-04-11
Last Update Posted: 2016-06-22
Locations: University Of Alabama At Birmingham, Birmingham, Alabama, 35294, United States|Clinical Research Advantage Inc/Desert Clinical Research Llc, Mesa, Arizona, 85213, United States|Clinical Research Advantage, Inc., Phoenix, Arizona, 85018, United States|Elite Clinical Studies, Llc, Phoenix, Arizona, 85018, United States|Arkansas Clinical Research, Little Rock, Arkansas, 72205, United States|Torrance Clinical Research Institute Inc., Lomita, California, 90717, United States|Randall G. Shue, Do, Inc., Los Angeles, California, 90023, United States|National Research Institute, Los Angeles, California, 90057, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Cassidy Medical Group/Clinical Research Advantage, Vista, California, 92083, United States|Palm Springs Research Institute, Hialeah, Florida, 33012, United States|Fpa Clinical Research, Kissimmee, Florida, 34741, United States|International Research Associates, Llc, Miami, Florida, 33183, United States|Omega Research Consultants, Llc, Orlando, Florida, 32804, United States|Compass Research East, Llc, Oviedo, Florida, 32765, United States|Palm Harbor Medical Associates, Palm Harbor, Florida, 34684, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Clinical Research Advantage, Evansville, Indiana, 47714, United States|Associated Internal Medicine Specialists, Battle Creek, Michigan, 49015, United States|Jackson Clinic, Rolling Fork, Mississippi, 39159, United States|Premier Research, Trenton, New Jersey, 08611, United States|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|Sterling Research Grp, Ltd., Cincinnati, Ohio, 45246, United States|Endocrine Associates, Houston, Texas, 77004, United States|Sam Clinical Research Center, San Antonio, Texas, 78229, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23454, United States|Local Institution, Broumov, 550 01, Czech Republic|Local Institution, Pardubice, 530 02, Czech Republic|Local Institution, Praha 10, 100 00, Czech Republic|Local Institution, Praha 4, 149 00, Czech Republic|Local Institution, Pribram V, 261 95, Czech Republic|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Zapopan, Jalisco, 45116, Mexico|Local Institution, Zapopan, Jalisco, 45200, Mexico|Local Institution, Monterrey, Nuevo Leon, 64060, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Aguascalientes, 20127, Mexico|Local Institution, Bialystok, 15-435, Poland|Local Institution, Krakow, 30-015, Poland|Local Institution, Ruda Slaska, 41-709, Poland|Local Institution, Warszawa, 00-465, Poland|Local Institution, Warszawa, 01-868, Poland|Local Institution, Warszawa, 03-003, Poland|Local Institution, Zory, 44-240, Poland|Clinical Research Puerto Rico, San Juan, 00909, Puerto Rico|Local Institution, Bucharest, 010825, Romania|Local Institution, Bucharest, 070208, Romania|Local Institution, Constanta, 900591, Romania|Local Institution, Craiova, 200349, Romania|Local Institution, Galati, 800098, Romania|Local Institution, Ploiesti, 100097, Romania|Local Institution, Kursk, 305035, Russian Federation|Local Institution, Moscow, 119034, Russian Federation|Local Institution, Saint-petersburg, 194044, Russian Federation|Local Institution, St. Petersburg, 194044, Russian Federation|Local Institution, St. Petersburg, 194156, Russian Federation|Local Institution, St. Petersburg, 195257, Russian Federation|Local Institution, St. Petersburg, 197136, Russian Federation|Local Institution, St.petersburg, 195112, Russian Federation|Local Institution, St.petersburg, 197022, Russian Federation|Local Institution, Yaroslaval, 150062, Russian Federation|Local Institution, Portsmouth, Hants, PO3 6LY, United Kingdom|Local Institution, Newport, Isle of Wight, PO30 5TG, United Kingdom|Local Institution, Liverpool, Merseyside, L7 8XP, United Kingdom|Local Institution, Chippenham, Wiltshire, SN15 1HP, United Kingdom|Local Institution, Bedfordshire, SG19 3JR, United Kingdom|Local Institution, London, W6 7HY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01646320

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details
D447 Saxagliptin small molecule DB06335 Details
D089 Metformin small molecule DB00331 Details