Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
NCT ID: NCT01609582
Last Updated: 2015-10-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
3207 participants
INTERVENTIONAL
2012-06-30
2014-05-31
Brief Summary
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Detailed Description
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The study will enroll approximately 5000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* TAK-875 50 mg.
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to record any time they have low blood sugar symptoms in a diary.
This multi-centre trial will be conducted worldwide, in approximately 700 sites. The overall time to participate in this study is 6 years. Participants will make up to approximately 24 visits to the clinic, with telephone visits conducted on an alternate 6 month schedule starting from Month 27.
Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.
For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAK-875 50 mg
TAK-875 50 mg tablets, orally, once daily for up to 6 years.
TAK-875
TAK-875 tablets
Placebo
TAK-875 placebo-matching tablets, orally, once daily for up to 6 years.
TAK-875 Placebo
TAK-875 placebo-matching tablets
Interventions
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TAK-875
TAK-875 tablets
TAK-875 Placebo
TAK-875 placebo-matching tablets
Eligibility Criteria
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Inclusion Criteria
2. The patient or, when applicable, the patient's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Has a diagnosis of type 2 diabetes mellitus.
4. Has an glycosylated hemoglobin (HbA1c) level between 7.0% and 10.5%, inclusive, at Screening. HbA1c testing may be repeated once during Screening.
5. Meets at least one (1) of the following three (3) High Risk Categories (a-c ):
1. A documented history of myocardial infarction (MI) occurring no less than 2 months (60 days) and no greater than 24 months prior to Screening.
2. Documented symptomatic peripheral arterial disease (PAD) (at least one (1) of the following three (3) criteria must be satisfied): i) Current intermittent claudication together with documented ankle-brachial index ≤0.85. ii) History of previous vascular intervention for intermittent claudication or resting limb ischemia (example: amputation for arterial disease, peripheral bypass, or history of angioplasty/stenting). iii) History of symptomatic carotid artery disease (requiring revascularization with carotid endarterectomy (CEA) or stenting).
3. Documented cerebrovascular disease (at least one (1) of the following two (2) criteria must be satisfied): i) A history of transient ischemic attack (TIA) confirmed by a neurologist no greater than 24 months prior to screening and clinically and neurologically stable at randomization. ii) A history of ischemic stroke (IS) (with a Modified Rankin Scale Score ≤3 documented prior to Randomization) not less than 2 months (60 days) and no greater than 24 months prior to Screening, and clinically and neurologically stable at Randomization. The Modified Rankin Scale is located in appendix in protocol.
Or meets at least one (1) of the following five (5) Intermediate Risk Categories (d-h):
4. Stable angina with coronary disease documented by the presence of inducible ischemia or scar by stress myocardial perfusion imaging (MPI), echocardiogram or magnetic resonance imaging (MRI) in the past 24 months.
5. Multi vessel coronary disease, based on coronary angiography, with or without angina, documented by \>50% diameter stenosis in at least 2 of the 3 major coronary distributions.
6. A history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 2 months prior to Screening.
7. The subject has diabetic nephropathy plus (2) of the clinical criteria listed below (i. to vi.). Diabetic nephropathy is defined as either urinary albumin excretion ≥ 30 µg/mg creatinine (3.4 mg/mmol creatinine) (based on a random spot collection) or urinary albumin excretion ≥ 30 mg/24h (based on a 24 h or timed collection). Results must be confirmed on at least two specimens collected within 12 months prior to Screening and no more than 6 months apart: i)Duration of diabetes ≥ 10 years on pharmacological treatment documented within medical records. ii) Confirmed systolic blood pressure (SBP) ≥150 mm Hg on 2 separate days during Screening despite treatment with at least 2 anti-hypertensive medications administered at doses considered optimal by local standard of care. iii) Presence of dyslipidemia as defined by any one (1) of the following confirmed at screening: A. Low density lipoprotein (LDL) \> 100 mg/dl (2.59 mmol/L) while on statin therapy administered at maximum tolerated dose or optimal dose based on local standard of care for at least 4 weeks prior to screening. B. LDL \> 130 mg/dL (3.37 mmol/L) when not on statin therapy. C. High density lipoprotein (HDL) \< 40 mg/dL (1.04 mmol/L) in males or \< 45 mg/dL (1.17 mmol/L) in females. D. Fasting Triglyceride \>200 mg/dL(2.26 mmol/L). iv) Currently smoking \>10 cigarettes per day at Screening. v) Male ≥65 years of age or female ≥70 years of age. vi) Highly selective C-reactive protein (hs-CRP) \> 2.0 mg/L in the absence of intercurrent infection or acute process.
h.) The subject meets at least five (5) of the following clinical criteria: i.) Duration of diabetes ≥10 years on pharmacological treatment documented within medical records. ii) Confirmed systolic blood pressure (SBP) ≥150 mm Hg on 2 separate days during Screening despite treatment with at least 2 anti-hypertensive medications administered at doses considered optimal by local standard of care. iii) Presence of dyslipidemia as defined by any one (1) of the following confirmed at screening: A. Low density lipoprotein (LDL) \> 100 mg/dl (2.59 mmol/L) while on statin therapy administered at maximum tolerated dose or optimal dose based on local standard of care for at least 4 weeks prior to screening. B. LDL \> 130 mg/dL (3.37 mmol/L) when not on statin therapy. C. High density lipoprotein (HDL) \< 40 mg/dL (1.04 mmol/L) in males or \< 45 mg/dL (1.17 mmol/L) in females. D. Fasting Triglyceride \>200 mg/dL(2.26 mmol/L). iv) Currently smoking \>10 cigarettes per day at Screening. v) Male ≥65 years of age or female ≥70 years of age. vi) Highly selective C-reactive protein (hs-CRP) \> 2.0 mg/L in the absence of intercurrent infection or acute process.
6. Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations in patient diaries.
7. A female of childbearing potential who is sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug.
8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) and if ALT or AST elevated above ULN, have chronic, well-compensated liver disease documented by usual clinical parameters.
7. Has ALT and/or AST levels \>3.0x ULN at Screening.
8. Has a total bilirubin level \>ULN at Screening. Exception: if a patient has documented Gilbert's Syndrome, the patient will be allowed with an elevated bilirubin level per the investigator's discretion.
9. Has an glomerular filtration rate (estimated) (eGFR) ≤ 15 mL/min/1.73m2 based on Modification of Diet in Renal Disease (MDRD) calculation at Screening and is currently on dialysis or expected to start dialysis within the next 6 months.
10. Has uncontrolled thyroid disease, as determined by the investigator and/or clinical investigation.
11. Has a known history of infection with human immunodeficiency virus (HIV).
12. Has a known active infection with Hepatitis B virus (HBV), or Hepatitis C virus (HCV) requiring antiviral treatment.
13. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
14. Has any major illness or condition that, in the investigator's opinion, prohibits the patient from participating in the study or meeting the planned visit schedule.
15. Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to TAK-875.
16. If female, is pregnant (confirmed by laboratory testing, ie, serum or urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
17. Is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
18. Has a history of cancer that has been in remission for \<5 years prior to Screening. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed.
Exclusion Criteria
2. Has been randomized into a previous TAK-875 study.
3. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, biological or legally adopted child, or sibling) or may consent under duress
4. Is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
5. Is hemodynamically unstable, including severe heart failure (New York Heart Association Class IV) at Screening.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Dothan, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
Pell City, Alabama, United States
Goodyear, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
El Cajon, California, United States
Fresno, California, United States
Fullerton, California, United States
La Mesa, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
National City, California, United States
Newport Beach, California, United States
Orange, California, United States
Paramount, California, United States
Pismo Beach, California, United States
Redondo Beach, California, United States
San Diego, California, United States
San Francisco, California, United States
San Franciso, California, United States
Stockton, California, United States
Thousand Oaks, California, United States
Torrance, California, United States
Valley Village, California, United States
Westlake Village, California, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Bridgeport, Connecticut, United States
Danbury, Connecticut, United States
Seaford, Delaware, United States
Washington D.C., District of Columbia, United States
Boynton Beach, Florida, United States
Brandon, Florida, United States
Chipley, Florida, United States
Clearwater, Florida, United States
Cocoa, Florida, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Crystal River, Florida, United States
Delray Beach, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Jacksonville Beach, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Ocala, Florida, United States
Oviedo, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Trinity, Florida, United States
Vero Bearch, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Calhoun, Georgia, United States
Conyers, Georgia, United States
Cumming, Georgia, United States
Norcross, Georgia, United States
Roswell, Georgia, United States
Suwanee, Georgia, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
LaGrange, Illinois, United States
Springfield, Illinois, United States
Anderson, Indiana, United States
Avon, Indiana, United States
Elkhart, Indiana, United States
Greenfield, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
Ames, Iowa, United States
Council Bluffs, Iowa, United States
Waterloo, Iowa, United States
Augusta, Kansas, United States
Hutchinson, Kansas, United States
Newton, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Elizabethtown, Kentucky, United States
Marrero, Louisiana, United States
Monroe, Louisiana, United States
Natchitoches, Louisiana, United States
New Orleans, Louisiana, United States
Sherveport, Louisiana, United States
Portland, Maine, United States
Annapolis, Maryland, United States
Balitmore, Maryland, United States
Baltimore, Maryland, United States
Fall River, Massachusetts, United States
Hyannis, Massachusetts, United States
Natick, Massachusetts, United States
Springfield, Massachusetts, United States
Bay City, Michigan, United States
Cadillac, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Mount Clemens, Michigan, United States
Novi, Michigan, United States
Pontiac, Michigan, United States
Saginaw, Michigan, United States
Troy, Michigan, United States
Baxter, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Paul, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Nashua, New Hampshire, United States
Bridgewater, New Jersey, United States
Elizabeth, New Jersey, United States
Haddon Heights, New Jersey, United States
Linden, New Jersey, United States
Mine Hill, New Jersey, United States
Somerset, New Jersey, United States
South Plainfield, New Jersey, United States
Toms Rivers, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Mineola, New York, United States
New York, New York, United States
Saratoga Springs, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
Burlington, North Carolina, United States
Calabash, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Lenoir, North Carolina, United States
Mooresville, North Carolina, United States
Morganton, North Carolina, United States
Raleigh, North Carolina, United States
Rocky Mount, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Fairview Park, Ohio, United States
Gallipolis, Ohio, United States
Kettering, Ohio, United States
Marion, Ohio, United States
Middleburg Heights, Ohio, United States
Perrysburg, Ohio, United States
Springfield, Ohio, United States
Toledo, Ohio, United States
Willoughby Hills, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Chambersburg, Pennsylvania, United States
Hanleysville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Levittown, Pennsylvania, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphi, Pennsylvania, United States
Scotland, Pennsylvania, United States
Uniontown, Pennsylvania, United States
East Providence, Rhode Island, United States
Pawtucket, Rhode Island, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Laurens, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Crossville, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Oak Ridge, Tennessee, United States
Tullahoma, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Katy, Texas, United States
Midland, Texas, United States
Odessa, Texas, United States
Pearland, Texas, United States
San Antonio, Texas, United States
Spring, Texas, United States
Tomball, Texas, United States
Victoria, Texas, United States
Bountiful, Utah, United States
Layton, Utah, United States
Salt Lake City, Utah, United States
Alexandria, Virginia, United States
Danville, Virginia, United States
Falls Church, Virginia, United States
Hampton, Virginia, United States
Manassas, Virginia, United States
Wenatchee, Washington, United States
Huntington, West Virginia, United States
Lewisburg, West Virginia, United States
La Crosse, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Bahía Blanca, Buenos Aires, Argentina
Haedo, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Loma Hermosa, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
San Nicolás de los Arroyos, Buenos Aires, Argentina
Zárate, Buenos Aires, Argentina
Trelew, Chubut Province, Argentina
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Corrientes, Corrientes Province, Argentina
Córdoba, Córdoba Province, Argentina
Villa Cabrera, Córdoba Province, Argentina
Villa María, Córdoba Province, Argentina
San Salvador de Jujuy, Jujy, Argentina
Godoy Cruz, Mendoza Province, Argentina
Mendoza, Mendoza Province, Argentina
Cipolletti, Río Negro Province, Argentina
Salta, Salta Province, Argentina
Rosario, Santa Fe Province, Argentina
Santa Fe, Santa Fe Province, Argentina
Venado Tuerto, Santa Fe Province, Argentina
Santiago del Estero, Santiago del Estero Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Córdoba, , Argentina
Rosario, , Argentina
Bruce, Australian Capital Territory, Australia
Canberra, Australian Capital Territory, Australia
Garran, Australian Capital Territory, Australia
Westmead, New South Wales, Australia
Wollongong, New South Wales, Australia
Brisbane, Queensland, Australia
Meadowbrook, Queensland, Australia
Milton, Queensland, Australia
Townsville, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Daw Park, South Australia, Australia
Elizabeth Vale, South Australia, Australia
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Sale, Victoria, Australia
Joondalup, Western Australia, Australia
Bruce, , Australia
Garran, , Australia
Fortaleza, Ceará, Brazil
Brasília, Federal District, Brazil
Goiânia, Goiás, Brazil
Campina Grande do Sul, Paraná, Brazil
Curitiba, Paraná, Brazil
Belém, Pará, Brazil
Recife, Pernambuco, Brazil
Canoas, Rio Grande do Sul, Brazil
Caxias do Sul, Rio Grande do Sul, Brazil
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santa Maria, Rio Grande do Sul, Brazil
Marília, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Blagoevgrad, , Bulgaria
Byala, , Bulgaria
Kazanlak, , Bulgaria
Pazardzhik, , Bulgaria
Plovdiv, , Bulgaria
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Spruce Grove, Alberta, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Brampton, Ontario, Canada
Etobicoke, Ontario, Canada
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
Oakville, Ontario, Canada
Ottawa, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Gatineau, Quebec, Canada
Laval, Quebec, Canada
Longueuil, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Saint-Laurent, Quebec, Canada
Čakovec, , Croatia
Karlovac, , Croatia
Koprivnica, , Croatia
Krapinske Toplice, , Croatia
Osijek, , Croatia
Rijeka, , Croatia
Sisak, , Croatia
Slavonski Brod, , Croatia
Split, , Croatia
Virovitica, , Croatia
Zadar, , Croatia
Zagreb, , Croatia
Choceň, , Czechia
České Budějovice, , Czechia
Jindřichův Hradec, , Czechia
Kroměříž, , Czechia
Mariánské Lázně, , Czechia
Moravský Krumlov, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Ostrava - Moravska Ostrava, , Czechia
Ostrava - Vitkovice, , Czechia
Prague, , Czechia
Praha 4 - Krc, , Czechia
Slaný, , Czechia
Trutnov, , Czechia
Ústí nad Labem, , Czechia
Paide, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Corbeil Essonne, Essonne, France
Corbeil-Essonnes, Essonne, France
Pessac, Gironde, France
Nanterre, Hauts de Seine, France
Nantes, Loire Atlantique, France
Paris, Paris, France
Pierre-Bénite, Rhone, France
Friedrichstal, Baden-Wurttemberg, Germany
Falkensee, Brandenburg, Germany
Hamburg, City state of Hamburg, Germany
Kelkheim, Hesse, Germany
Cologne, North Rhine-Westphalia, Germany
Dortmund, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Goch, North Rhine-Westphalia, Germany
Kamp-Lintfort, North Rhine-Westphalia, Germany
Bad Kreuznach, Rhineland-Palatinate, Germany
Dippoldiswalde, Saxony, Germany
Dresden, Saxony, Germany
Hohenmölsen, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Hong Kong, , Hong Kong
New Territories, , Hong Kong
Baja, , Hungary
Balatonfüred, , Hungary
Budaörs, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Gödöllő, , Hungary
Gyula, , Hungary
Kecskemét, , Hungary
Kistelek, , Hungary
Komárom, , Hungary
Makó, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Szikszó, , Hungary
Szombathely, , Hungary
Úrhida, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Ashkelon, , Israel
Beer Yaakov, , Israel
Beersheba, , Israel
Giv‘atayim, , Israel
Hadera, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Raanana, , Israel
Safed, , Israel
Tel Aviv, , Israel
Florence, Firenze, Italy
Milan, Milano, Italy
San Donato Milanese, Milano, Italy
Sesto San Giovanni, Milano, Italy
Pavia, Pavia, Italy
Daugavpils, , Latvia
Jelgava, , Latvia
Limbaži, , Latvia
Ogre, , Latvia
Riga, , Latvia
Talsi, , Latvia
Valmiera, , Latvia
Alytus, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Johor Bahru, Johor, Malaysia
Alor Star, Kedah, Malaysia
Kelantan, Kelantan, Malaysia
Kota Bharu, Kelantan, Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
Lembah Pantai, Kuala Lumpur, Malaysia
Malacca, Melaka, Malaysia
Ipoh, Perak, Malaysia
Taiping, Perak, Malaysia
Taiping, Perak, Perak, Malaysia
Kuala Selangor, Selangor, Malaysia
Petaling Jaya, Selangor, Malaysia
Terengganu, Terengganu, Malaysia
Kuala Selangor, , Malaysia
Terengganu, , Malaysia
Aguascalientes, Aguascalientes, Mexico
Tijuana, Baja California Norte, Mexico
Chihuahua City, Chihuahua, Mexico
Torreón, Coahuila, Mexico
Durango, Durango, Mexico
Acapulco de Juárez, Guerrero, Mexico
Pachuca, Hidalgo, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Cuauhtémoc, Mexico City, Mexico
Mexico City, Mexico City, Mexico
Morelia, Michoacán, Mexico
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo Le=n, Mexico
Monterrey, Nuevo León, Mexico
San Luis Potosí City, San Luis Potos, Mexico
Culiacán, Sinaloa, Mexico
Cuautitlán Izcalli, State of Mexico, Mexico
Metepec, State of Mexico, Mexico
Tamaulipas, Tamaulipas, Mexico
Xalapa, Veracruz, Mexico
Mérida, Yucatán, Mexico
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Palmerston North, , New Zealand
Tauranga, , New Zealand
Wellington, , New Zealand
Callao, , Peru
Cusco, , Peru
Huacho, , Peru
Ica, , Peru
La Libertad, , Peru
Lima, , Peru
Piura, , Peru
Baguio City, , Philippines
Cebu City, , Philippines
Dasmariñas City, Cavite, , Philippines
Davao City, , Philippines
Iloilo City, , Philippines
Marikina City, , Philippines
Quezon City, , Philippines
Tarlac City, , Philippines
Taytay, , Philippines
Bialystok, , Poland
Gdansk, , Poland
Gliwice, , Poland
Grodzisk Mazowiecki, , Poland
Kamieniec Ząbkowicki, , Poland
Lodz, , Poland
Lublin, , Poland
Oświęcim, , Poland
Parczew, , Poland
Poznan, , Poland
Puławy, , Poland
Radom, , Poland
Ruda Śląska, , Poland
Rzeszów, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Łęczyca, , Poland
Bacau, , Romania
Baia Mare, , Romania
Brasov, , Romania
Bucharest, , Romania
Galati, , Romania
Iași, , Romania
Oradea, , Romania
Ploieşti, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Barnaul, , Russia
Kazan', , Russia
Kemerovo, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Pushkin, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Yaroslavl, , Russia
Bratislava, , Slovakia
Komárno, , Slovakia
Košice, , Slovakia
Levice, , Slovakia
Lučenec, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
Nové Mesto nad Váhom, , Slovakia
Prešov, , Slovakia
Svidník, , Slovakia
Šahy, , Slovakia
Trenčín, , Slovakia
Žilina, , Slovakia
Port Elizabeth, Eastern Cape, South Africa
Bloemfontein, Free State, South Africa
Johannesburg, Gauteng, South Africa
Kempton Park, Gauteng, South Africa
Krugersdorp, Gauteng, South Africa
Lenasia, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
Worcester, Western Cape, South Africa
Wŏnju, Gangwon-do, South Korea
Seongnam-si, Gyeonggi-do, South Korea
Yangsan, Gyeongsangnam-do, South Korea
Jeonju, Jeollabuk-do, South Korea
Busan, , South Korea
Gyeonggi-do, , South Korea
Seoul, , South Korea
Douliu, , Taiwan
Kaohsiung City, , Taiwan
New Taipei City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Bangkoknoi, Bangkok, Thailand
Dusit, Bangkok, Thailand
Patumwan, Bangkok, Thailand
Rachathevi, Bangkok, Thailand
Rajtevi, Bangkok, Thailand
Ratchathewi, Bangkok, Thailand
Muang, Changwat Chiang Rai, Thailand
Muang, Changwat Khon Kaen, Thailand
Muang, Changwat Nakhon Ratchasima, Thailand
Muang, Chiang Mai, Thailand
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Luhansk, , Ukraine
Mykolayiv, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Simferopol, , Ukraine
Ternopil, , Ukraine
Vinnycia, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhia, , Ukraine
Cardiff, Cardiff, United Kingdom
Truro, Cornwall, United Kingdom
Exeter, Devon, United Kingdom
Plymouth, Devon, United Kingdom
Torquay, Devon, United Kingdom
Hull, East Riding of Yorkshire, United Kingdom
Bexhill-on-Sea, East Sussex, United Kingdom
Portsmouth, Hampshire, United Kingdom
Watford, Hertfordshire, United Kingdom
Gillingham, Kent, United Kingdom
Thornton-Cleveleys, Lancashire, United Kingdom
Leicester, Leicestershire, United Kingdom
Liverpool, Merseyside, United Kingdom
Harrow, Middlesex, United Kingdom
Northwood, Middlesex, United Kingdom
Stoke-on-Trent, Staffordshire, United Kingdom
Swansea, West Glamorgan, United Kingdom
Countries
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References
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Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.
Menon V, Lincoff AM, Nicholls SJ, Jasper S, Wolski K, McGuire DK, Mehta CR, Rosenstock J, Lopez C, Marcinak J, Cao C, Nissen SE; GRAND 306 Investigators. Fasiglifam-Induced Liver Injury in Patients With Type 2 Diabetes: Results of a Randomized Controlled Cardiovascular Outcomes Safety Trial. Diabetes Care. 2018 Dec;41(12):2603-2609. doi: 10.2337/dc18-0755.
Other Identifiers
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2011-001732-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1129-7824
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-875_306CTIL
Identifier Type: REGISTRY
Identifier Source: secondary_id
DOH-27-0313-4117
Identifier Type: REGISTRY
Identifier Source: secondary_id
12/SC/0504
Identifier Type: REGISTRY
Identifier Source: secondary_id
NMRR-12-433-12087
Identifier Type: REGISTRY
Identifier Source: secondary_id
PHRR130916-000119
Identifier Type: REGISTRY
Identifier Source: secondary_id
1015031332
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-875_306
Identifier Type: -
Identifier Source: org_study_id
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