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Clinical Trial Details

Trial ID: L6057
Source ID: NCT01456195
Associated Drug: Placebo
Title: Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01456195/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: Fasiglifam
Outcome Measures: Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis., Baseline and Week 24 | Secondary: Incidence of HbA1c <7%, The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24., Week 24|Change From Baseline in Fasting Plasma Glucose, The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis., Baseline and Week 24|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT), The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 421
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-11
Completion Date: 2013-07
Results First Posted: 2016-04-05
Last Update Posted: 2016-04-05
Locations: Dothan, Alabama, United States|Muscle Shoals, Alabama, United States|Goodyear, Arizona, United States|Phoenix, Arizona, United States|Long Beach, California, United States|North Hollywood, California, United States|Norwalk, California, United States|Palm Springs, California, United States|Pismo Beach, California, United States|Boynton Beach, Florida, United States|Bradenton, Florida, United States|Coral Gables, Florida, United States|Hialeah, Florida, United States|Largo, Florida, United States|New Port Richey, Florida, United States|Orlando, Florida, United States|Pembroke Pines, Florida, United States|Decatur, Georgia, United States|Chicago, Illinois, United States|Avon, Indiana, United States|Greenfield, Indiana, United States|Muncie, Indiana, United States|Council Bluffs, Iowa, United States|Topeka, Kansas, United States|Lexington, Kentucky, United States|Oxon Hill, Maryland, United States|Flint, Michigan, United States|Picayune, Mississippi, United States|Omaha, Nebraska, United States|Elizabeth, New Jersey, United States|Charlotte, North Carolina, United States|Greensboro, North Carolina, United States|Mooresville, North Carolina, United States|Morganton, North Carolina, United States|Raleigh, North Carolina, United States|Maumee, Ohio, United States|Oklahoma City, Oklahoma, United States|Harleysville, Pennsylvania, United States|Levittown, Pennsylvania, United States|Uniontown, Pennsylvania, United States|Greer, South Carolina, United States|Crossville, Tennessee, United States|Carrollton, Texas, United States|Dallas, Texas, United States|El Pasco, Texas, United States|Fort Worth, Texas, United States|Ft. Worth, Texas, United States|Houston, Texas, United States|Irving, Texas, United States|New Braunfels, Texas, United States|San Antonio, Texas, United States|Spring, Texas, United States|Tomball, Texas, United States|Salt Lake City, Utah, United States|Burke, Virginia, United States|Manassas, Virginia, United States|Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina|Villa Cabrera, Cordoba, Argentina|Ciudad Autonoma Buenos Aires, Argentina|Cordoba, Argentina|Corrientes, Argentina|Mendoza, Argentina|Byala, Bulgaria|Plovdiv, Bulgaria|Ruse, Bulgaria|Sofia, Bulgaria|Varna, Bulgaria|Guatemala City, Guatemala|Guatemala, Guatemala|Quetzaltenango, Guatemala|Zacapa, Guatemala|Budapest, Hungary|Debrecen, Hungary|Kecskemet, Hungary|Komarom, Hungary|Szikszo, Hungary|Zalaegerszeg, Hungary|Mexico, Distrito Federal, Mexico|Monterrey, Nuevo León, Mexico|Banska Bystrica, Slovakia|Bratislava, Slovakia|Dolny Kubin, Slovakia|Komarno, Slovakia|Levice, Slovakia|Pezinok, Slovakia|Prievidza, Slovakia|Trebisov, Slovakia|Trencin, Slovakia|Zilina, Slovakia|Dnipropetrovsk, Ukraine|Kharkiv, Ukraine|Kyiv, Ukraine|Odesa, Ukraine|Simferopol, Ukraine|Ternopil, Ukraine|Vinnytsia, Ukraine|Zaporizhzhia, Ukraine
URL: https://clinicaltrials.gov/show/NCT01456195

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress