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Clinical Trial Details

Trial ID: L3172
Source ID: NCT01834274
Associated Drug: Fasiglifam (Tak-875)
Title: Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01834274/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Fasiglifam (TAK-875)|DRUG: Fasiglifam (TAK-875) Placebo|DRUG: Sitagliptin|DRUG: Sitagliptin Placebo|DRUG: Metformin
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 or final visit relative to Baseline. A negative change from Baseline indicated improvement., Baseline and Week 24 | Secondary: Percentage of Participants With HbA1c <7% at Week 24, The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment., Week 24|Change From Baseline in Fasting Plasma Glucose (FPG), The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 96
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-06
Completion Date: 2014-03
Results First Posted: 2015-09-28
Last Update Posted: 2015-09-28
Locations: Huntsville, Alabama, United States|Chandler, Arizona, United States|Glendale, Arizona, United States|Little Rock, Arkansas, United States|Fresno, California, United States|Garden Grove, California, United States|Modesto, California, United States|San Diego, California, United States|Thousand Oaks, California, United States|Lakewood, Colorado, United States|Hallandale Beach, Florida, United States|Hialeah, Florida, United States|Miami Lakes, Florida, United States|Miami, Florida, United States|North Miami Beach, Florida, United States|North Miami, Florida, United States|Pembroke Pines, Florida, United States|Sanford, Florida, United States|Atlanta, Georgia, United States|Conyers, Georgia, United States|Evans, Georgia, United States|Boise, Idaho, United States|Chicago, Illinois, United States|Evanston, Illinois, United States|Council Bluffs, Iowa, United States|Augusta, Kansas, United States|Omaha, Nebraska, United States|New York, New York, United States|Durham, North Carolina, United States|Greensboro, North Carolina, United States|Hickory, North Carolina, United States|Carlisle, Ohio, United States|Oklahoma City, Oklahoma, United States|Medford, Oregon, United States|Fort Mill, South Carolina, United States|Laurens, South Carolina, United States|Spartanburg, South Carolina, United States|Knoxville, Tennessee, United States|Austin, Texas, United States|Odessa, Texas, United States|San Antonio, Texas, United States|Sugar Land, Texas, United States|Victoria, Texas, United States|Salt Lake City, Utah, United States|Coronel Suarez, Buenos Aires, Argentina|Rosario, Santa Fe, Argentina|Ciudad Autonoma Buenos Aires, Argentina|Calgary, Alberta, Canada|Red Deer, Alberta, Canada|Vancouver, British Columbia, Canada|Victoria, British Columbia, Canada|Winnipeg, Manitoba, Canada|Etobicoke, Ontario, Canada|London, Ontario, Canada|Toronto, Ontario, Canada|Karlovac, Croatia|Krapinske Toplice, Croatia|Slavonski Brod, Croatia|Virovitica, Croatia|Zagreb, Croatia|Budapest, Hungary|Godollo, Hungary|Kistarcsa, Hungary|Satoraljaujhely, Hungary|Szeged, Hungary|Seri Manjung, Perak, Malaysia|Taiping, Perak, Perak, Malaysia|Taiping, Perak, Malaysia|Putrajaya, Selangor, Malaysia|Kelantan, Malaysia|Kuala Lumpur, Malaysia|Ica, Peru|Lima, Peru|Cebu City, Philippines|Iloilo City, Philippines|Marikina City, Philippines|Pasig, Philippines|Quezon City, Philippines|West Fairview, Quezon City, Philippines|Gdansk, Poland|Lodz, Poland|Oswiecim, Poland|Rzeszow, Poland|Sobotka, Poland|Wroclaw, Poland|Zgierz, Poland|Barnaul, Russian Federation|Kemerovo, Russian Federation|Novosibirsk, Russian Federation|St. Petersburg, Russian Federation|Bloemfontein, Free State, South Africa|Pretoria, Gauteng, South Africa|Durban, KwaZulu-Natal, South Africa|Cape Town, Western Cape, South Africa|Bangkoknoi, Bangkok, Thailand|Rajathevee, Bangkok, Thailand|Muang, Khon Kaen, Thailand|Klongluang, Pathum Thani, Thailand|Hat Yai, Songkhla, Thailand|Ivano-Frankivsk, Ukraine|Kharkiv, Ukraine|Kyiv, Ukraine|Lviv, Ukraine|Vinnytsia, Ukraine
URL: https://clinicaltrials.gov/show/NCT01834274

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details