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Clinical Trial Details

Trial ID:	L3329
Source ID:	NCT01481116
Associated Drug:	Tak-875
Title:	Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes
Acronym:
Status:	TERMINATED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT01481116/results
Conditions:	Diabetes Mellitus, Type 2
Interventions:	DRUG: TAK-875\|DRUG: TAK-875\|DRUG: Glimepiride
Outcome Measures:	Primary: Change From Baseline in HbA1c at Weeks 78 and 104, The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline., Baseline and Weeks 78 and 104 \| Secondary: Percentage of Participants With Hypoglycemia, Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (\<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded., Day 1 up to Weeks 78 and 104\|Change From Baseline in Body Weight at Weeks 78 and 104, The change between the body weight to be collected at Weeks 78 and 104 relative to baseline., Baseline and Weeks 78 and 104\|Change From Baseline in HbA1c at Weeks 26 and 52, The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline., Baseline and Weeks 26 and 52\|Percentage of Participants With HbA1c <7%, Weeks 26, 52, 78 and 104\|Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia, Weeks 26, 52, 78 and 104\|Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104, The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline., Baseline and Weeks 26, 52, 78 and 104
Sponsor/Collaborators:	Sponsor: Takeda
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	2454
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2012-01
Completion Date:	2014-04
Results First Posted:	2016-06-01
Last Update Posted:	2016-06-01
Locations:	Dothan, Alabama, United States\|Muscle Shoals, Alabama, United States\|Goodyear, Arizona, United States\|Phoenix, Arizona, United States\|Tempe, Arizona, United States\|Long Beach, California, United States\|Mission Hills, California, United States\|North Hollywood, California, United States\|Norwalk, California, United States\|Pismo Beach, California, United States\|Bradenton, Florida, United States\|Clearwater, Florida, United States\|Coral Gables, Florida, United States\|Hialeah, Florida, United States\|Orlando, Florida, United States\|Pembroke Pines, Florida, United States\|Decatur, Georgia, United States\|Avon, Indiana, United States\|Topeka, Kansas, United States\|Oxon Hill, Maryland, United States\|Flint, Michigan, United States\|Jackson, Mississippi, United States\|Omaha, Nebraska, United States\|Elizabeth, New Jersey, United States\|Calabash, North Carolina, 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\|Greer, South Carolina, United States\|Spartanburg, South Carolina, United States\|Dallas, Texas, United States\|El Paso, Texas, United States\|Ft. Worth, Texas, United States\|Houston, 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\|Hampton, Virginia, United States\|Manassas, Virginia, United States\|Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina\|Rosario, Santa Fe, Argentina\|Ciudad Autonoma Buenos Aires, Argentina\|Cordoba, Argentina\|Corrientes, Argentina\|Canberra, Australian Capital Territory, Australia\|Brookvale, New South Wales, Australia\|Mosman, New South Wales, Australia\|Woy Woy, New South Wales, Australia\|Canberra, Australia\|Blagoevgrad, Bulgaria\|Gabrovo, Bulgaria\|Pleven, Bulgaria\|Plovdiv, Bulgaria\|Sevlievo, Bulgaria\|Sofia, Bulgaria\|Stara Zagora, Bulgaria\|Varna, Bulgaria\|Victoria, British Columbia, Canada\|Oakville, Ontario, Canada\|Ottawa, Ontario, Canada\|Thornhill, Ontario, Canada\|Toronto, Ontario, Canada\|Laval, Quebec, Canada\|Longueuil, Quebec, Canada\|Mirabel, Quebec, Canada\|Pointe Claire, Quebec, Canada\|Ville Saint-Laurent, Quebec, Canada\|Bogota, Colombia\|Medellin, Colombia\|Benatky nad Jizerou, Czech Republic\|Brno, Czech Republic\|Ceske Budejovice, Czech Republic\|Chocen, Czech Republic\|Jindrichuv Hradec, Czech Republic\|Marianske Lazne, Czech Republic\|Olomouc, Czech Republic\|Ostrava - Moravska Ostrava, Czech Republic\|Ostrava - Vitkovice, Czech Republic\|Ostrava, Czech Republic\|Prague 10, Czech Republic\|Praha 10, Czech Republic\|Praha 4 - Krc, Czech Republic\|Praha 5, Czech Republic\|Praha 8, Czech Republic\|Znojmo, Czech Republic\|Paide, Estonia\|Rakvere, Estonia\|Saku, Estonia\|Tallinn, Estonia\|Tartu, Estonia\|Võru, Estonia\|Hong Kong, Hong Kong\|New Territories, Hong Kong\|Ashkelon, Israel\|Beer Sheva, Israel\|Beer Yaakov, Israel\|Beer-Sheva, Israel\|Givataim, Israel\|Hadera, Israel\|Haifa, Israel\|Holon, Israel\|Jerusalem, Israel\|Kfar-Saba, Israel\|Nahariya, Israel\|Petach Tikva, Israel\|Petach Tikwa, Israel\|Raanana, Israel\|Ramat Gan, Israel\|Ramat-Gan, Israel\|Rechovot, Israel\|Rishon le Zion, Israel\|Tel Aviv, Israel\|Tel-Aviv, Israel\|Zefat, Israel\|Jelgava, Latvia\|Limbazi, Latvia\|Ogre, Latvia\|Riga, Latvia\|Talsi, Latvia\|Valmiera, Latvia\|Alytus, Lithuania\|Kaunas, Lithuania\|Klaipeda, Lithuania\|Vilnius, Lithuania\|Ipoh, Perak, Malaysia\|Taiping, Perak, Perak, Malaysia\|Taiping, Perak, Malaysia\|Petaling Jaya, Selangor, Malaysia\|Kuala Lumpur, Malaysia\|Melaka, Malaysia\|Putrajaya, Malaysia\|Terengganu, Malaysia\|Mexico, Distrito Federal, Mexico\|Cuernavaca, Morelos, Mexico\|Auckland, New Zealand\|Christchurch, New Zealand\|Hamilton, New Zealand\|Palmerston North, New Zealand\|Rotorua, New Zealand\|Tauranga, New Zealand\|Wellington, New Zealand\|Cebu City, Philippines\|Davao City, Philippines\|Iloilo City, Philippines\|Lipa City, Philippines\|Quezon City, Philippines\|Tarlac, Philippines\|Taytay, Philippines\|Bialystok, Poland\|Bydgoszcz, Poland\|Gdansk, Poland\|Grodzisk Mazowiecki, Poland\|Kamieniec Zabkowicki, Poland\|Katowice, Poland\|Leczyca, Poland\|Lodz, Poland\|Lublin, Poland\|Oswiecim, Poland\|Parczew, Poland\|Plock, Poland\|Poznan, Poland\|Pulawy, Poland\|Ruda Slaska, Poland\|Rzeszow, Poland\|Sopot, Poland\|Torun, Poland\|Wroclaw, Poland\|Zgierz, Poland\|Bacau, Romania\|Baia Mare, Romania\|Bucuresti, Romania\|Constanta, Romania\|Iasi, Romania\|Oradea, Romania\|Ploiesti, Romania\|Targu Mures, Romania\|Timisoara, Romania\|Kazan, Russian Federation\|Kemerovo, Russian Federation\|Krasnoyarsk, Russian Federation\|Moscow, Russian Federation\|Novosibirsk, Russian Federation\|St. Petersburg, Russian Federation\|Yaroslavl, Russian Federation\|Port Elizabeth, Eastern Cape, South Africa\|Bloemfontein, Free State, South Africa\|Johannesburg, Gauteng, South Africa\|Kempton Park, Gauteng, South Africa\|Krugersdorp, Gauteng, South Africa\|Pretoria, Gauteng, South Africa\|Durban, KwaZulu-Natal, South Africa\|Middelburg, Mpumalanga, South Africa\|Cape Town, Western Cape, South Africa\|Somerset West, Western Cape, South Africa\|Stellenbosch, Western Cape, South Africa\|Worcester, Western Cape, South Africa\|Chia-Yi City, Taiwan\|New Taipei City, Taiwan\|Taichung, Taiwan\|Tainan, Taiwan\|Taipei, Taiwan\|Dnipropetrovsk, Ukraine\|Ivano-Frankivsk, Ukraine\|Kharkiv, Ukraine\|Kiev, Ukraine\|Kyiv, Ukraine\|Lugansk, Ukraine\|Lviv, Ukraine\|Mykolayiv, Ukraine\|Poltava, Ukraine\|Ternopil, Ukraine\|Vinnytsia, Ukraine\|Zaporizhzhia, Ukraine\|Cheadle, Cheshire, United Kingdom\|Plymouth, Devon, United Kingdom\|Hull, East Riding of Yorkshire, United Kingdom\|Bexhill on Sea, East Sussex, United Kingdom\|Watford, Hertfordshire, United Kingdom\|Thornton-Cleveleys, Lancashire, United Kingdom\|Liverpool, Merseyside, United Kingdom\|Northwood, Middlesex, United Kingdom\|Bath, Somerset, United Kingdom\|Swansea, South Glamorgan, United Kingdom\|Cardiff, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT01481116

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Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

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Associated Data

Associated NAFLD Drugs (0)