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Clinical Trial Details

Trial ID: L4715
Source ID: NCT01549964
Associated Drug: Fasiglifam (Tak-875)
Title: Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01549964/results
Conditions: Glycemic Control
Interventions: DRUG: Fasiglifam (TAK-875)|DRUG: Sitagliptin|DRUG: Placebo
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 was used for analysis with treatment, country, schedule, 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., Baseline and Week 24 | Secondary: Incidence of HbA1c <7%, Incidence (percentage) of participants with glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than 7% at Week 24., 24 Weeks|Change From Baseline in Fasting Plasma Glucose (FPG), The change between FPG collected at week 24 relative to Baseline. A MMRM model was used for analysis with treatment, country, schedule, 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., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 916
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-04
Completion Date: 2014-03
Results First Posted: 2016-06-02
Last Update Posted: 2016-06-02
Locations: Muscle Shoals, Alabama, United States|Mesa, Arizona, United States|Peoria, Arizona, United States|Phoenix, Arizona, United States|Chula Vista, California, United States|El Cajon, California, United States|La Mesa, California, United States|Laguna Hills, California, United States|National City, California, United States|Paramount, California, United States|San Diego, California, United States|Stockton, California, United States|Tustin, California, United States|West Hills, California, United States|Trumbull, Connecticut, United States|Coral Gables, Florida, United States|Jacksonville, Florida, United States|Miami, Florida, United States|New Port Richey, Florida, United States|Ocala, Florida, United States|West Palm Beach, Florida, United States|Meridian, Idaho, United States|Chicago, Illinois, United States|Greenfield, Indiana, United States|Muncie, Indiana, United States|Lexington, Kentucky, United States|Owensboro, Kentucky, United States|Hyattsville, Maryland, United States|Troy, Michigan, United States|Picayune, Mississippi, United States|St. Louis, Missouri, United States|Haddon Heights, New Jersey, United States|Rosedale, New York, United States|Calabash, North Carolina, United States|Charlotte, North Carolina, United States|Monroe, North Carolina, United States|Morehead City, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Cleveland, Ohio, United States|Dayton, Ohio, United States|Norman, Oklahoma, United States|Lancaster, Pennsylvania, United States|Levittown, Pennsylvania, United States|Spartanburg, South Carolina, United States|Crossville, Tennessee, United States|Memphis, Tennessee, United States|Carrollton, Texas, United States|Houston, Texas, United States|Irving, Texas, United States|Katy, Texas, United States|McKinney, Texas, United States|Plano, Texas, United States|San Antonio, Texas, United States|Spring, Texas, United States|Salt Lake City, Utah, United States|West Jordan, Utah, United States|Richmond, Virginia, United States|Camperdown, New South Wales, Australia|Maroubra, New South Wales, Australia|Redcliffe, Queensland, Australia|Adelaide, South Australia, Australia|Daw Park, South Australia, Australia|Box Hill, Victoria, Australia|Fitzroy, Victoria, Australia|Melbourne, Victoria, Australia|Byala, Bulgaria|Kazanlak, Bulgaria|Plovdiv, Bulgaria|Sofia, Bulgaria|Cakovec, Croatia|Karlovac, Croatia|Krapinske Toplice, Croatia|Rijeka, Croatia|Slavonski Brod, Croatia|Split, Croatia|Zadar, Croatia|Zagreb, Croatia|Beroun, Czech Republic|Brno, Czech Republic|Havlickuv Brod, Czech Republic|Kladno, Czech Republic|Kromeriz, Czech Republic|Mlada Boleslav, Czech Republic|Ostrava - Moravska Ostrava, Czech Republic|Ostrava, Czech Republic|Pardubice, Czech Republic|Pisek, Czech Republic|Plzen, Czech Republic|Praha 11, Czech Republic|Praha 2, Czech Republic|Praha 5, Czech Republic|Praha 6, Czech Republic|Praha 8, Czech Republic|Usti nad Labem, Czech Republic|Baja, Hungary|Balatonfured, Hungary|Budaors, Hungary|Budapest, Hungary|Debrecen, Hungary|Eger, Hungary|Godollo, Hungary|Gyongyos, Hungary|Gyula, Hungary|Hodmezovasarhely, Hungary|Kecskemet, Hungary|Kistelek, Hungary|Kisvarda, Hungary|Komarom, Hungary|Mohacs, Hungary|Nyiregyhaza, Hungary|Pecs, Hungary|Szeged, Hungary|Szekszard, Hungary|Szikszo, Hungary|Szolnok, Hungary|Szombathely, Hungary|Urhida, Hungary|Veszprem, Hungary|Zalaegerszeg, Hungary|Sesto San Giovanni, Milano, Italy|Firenze, Italy|Milano, Italy|Pavia, Italy|Goyang-si, Gyeonggi-do, Korea, Republic of|Seongnam-Si, Gyeonggi-do, Korea, Republic of|Incheon, Korea, Republic of|Seoul, Korea, Republic of|Johor Bahru, Johor, Malaysia|Alor Setar, Kedah, Malaysia|Kota Bharu, Kelantan, Malaysia|Cheras, Kuala Lumpur, Malaysia|Lembah Pantai, Kuala Lumpur, Malaysia|Petaling Jaya, Selangor, Malaysia|Kelantan, Malaysia|Kuala Lumpur, Malaysia|Banska Bystrica, Slovakia|Bardejov, Slovakia|Bratislava, Slovakia|Kosice - Saca, Slovakia|Kosice, Slovakia|Levice, Slovakia|Lucenec, Slovakia|Moldava nad Bodvou, Slovakia|Nitra, Slovakia|Pezinok, Slovakia|Presov, Slovakia|Prievidza, Slovakia|Sahy, Slovakia|Stropkov, Slovakia|Sturovo, Slovakia|Svidnik, Slovakia|Trebisov, Slovakia|Trencin, Slovakia|Zilina, Slovakia|Patumwan, Bangkok, Thailand|Rachathevi, Bangkok, Thailand|Rajtevi, Bangkok, Thailand|Ratchathewi, Bangkok, Thailand|Muang, Chiang Mai, Thailand|Muang, Nakhon Ratchasima, Thailand|Hatyai, Songkhla, Thailand|Bangkok, Thailand|Khon Kaen, Thailand
URL: https://clinicaltrials.gov/show/NCT01549964

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress