AzTrials
AzTrials

Type 2 DiabetesPhase 3NCT01609582

Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease

A Phase 3 study testing TAK-875 in people with Type 2 Diabetes and Cardiovascular Disease, run by Takeda at 584 sites in 32 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Cardiovascular Disease
What is being tested?
TAK-875
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,207 participants
Where
584 sitesin 32 countries
Study dates
Jun 2012to May 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
  • 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.
  • Has a diagnosis of type 2 diabetes mellitus.
  • Has an glycosylated hemoglobin (HbA1c) level between 7.0% and 10.5%, inclusive, at Screening. HbA1c testing may be repeated once during Screening.
  • Meets at least one (1) of the following three (3) High Risk Categories (a-c ):
  • A documented history of myocardial infarction (MI) occurring no less than 2 months (60 days) and no greater than 24 months prior to Screening.
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  • 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).
  • 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):
  • 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.
  • 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.
  • A history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 2 months prior to Screening.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Has received any investigational medication within 30 days prior to Screening or any investigational antidiabetic medication or excluded medications within 3 months prior to Screening.
  • Has been randomized into a previous TAK-875 study.
  • 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
  • Is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
  • Is hemodynamically unstable, including severe heart failure (New York Heart Association Class IV) at Screening.
  • Is hospitalized at the Screening Visit for the event associated with the CV inclusion criteria. (Patients who have been discharged from an acute hospital to a cardiac rehabilitation center or nursing home at the time of the Screening Visit or Randomization Visit are not excluded).
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  • Has ALT and/or AST levels >3.0x ULN at Screening.
  • 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.
  • 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.
  • Has uncontrolled thyroid disease, as determined by the investigator and/or clinical investigation.
  • Has a known history of infection with human immunodeficiency virus (HIV).
  • Has a known active infection with Hepatitis B virus (HBV), or Hepatitis C virus (HCV) requiring antiviral treatment.
  • Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
  • 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.
  • Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to TAK-875.
  • 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.
  • Is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  • 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.

Trial locations and contacts

584 sites in 32 countries.

584 sites in 32 countries

United States218 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexandria, Virginia

  • Study site

    Ames, Iowa

  • Study site

    Anaheim, California

  • Study site

    Anderson, Indiana

  • Study site

    Annapolis, Maryland

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Augusta, Kansas

  • Study site

    Austin, Texas

  • Study site

    Avon, Indiana

  • Study site

    Balitmore, Maryland

  • Study site

    Baltimore, Maryland

  • Study site

    Baxter, Minnesota

  • Study site

    Bay City, Michigan

  • Study site

    Birmingham, Alabama

  • Study site

    Bountiful, Utah

  • Study site

    Boynton Beach, Florida

  • Study site

    Brandon, Florida

  • Study site

    Bridgeport, Connecticut

  • Study site

    Bridgewater, New Jersey

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn, New York

  • Study site

    Buffalo, New York

  • Study site

    Burlington, North Carolina

  • Study site

    Cadillac, Michigan

  • Study site

    Calabash, North Carolina

  • Study site

    Calhoun, Georgia

  • Study site

    Canton, Ohio

  • Study site

    Carrollton, Texas

  • Study site

    Chambersburg, Pennsylvania

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Chipley, Florida

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Cocoa, Florida

  • Study site

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Conyers, Georgia

  • Study site

    Coral Gables, Florida

  • Study site

    Coral Springs, Florida

  • Study site

    Council Bluffs, Iowa

  • Study site

    Crossville, Tennessee

  • Study site

    Crystal River, Florida

  • Study site

    Cumming, Georgia

  • Study site

    Dallas, Texas

  • Study site

    Danbury, Connecticut

  • Study site

    Danville, Virginia

  • Study site

    Delray Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Dothan, Alabama

  • Study site

    Durham, North Carolina

  • Study site

    East Providence, Rhode Island

  • Study site

    El Cajon, California

  • Study site

    Elizabeth, New Jersey

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Elkhart, Indiana

  • Study site

    Fairview Park, Ohio

  • Study site

    Fall River, Massachusetts

  • Study site

    Falls Church, Virginia

  • Study site

    Flint, Michigan

  • Study site

    Fort Worth, Texas

  • Study site

    Fresno, California

  • Study site

    Fullerton, California

  • Study site

    Gallipolis, Ohio

  • Study site

    Goodyear, Arizona

  • Study site

    Greenfield, Indiana

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hampton, Virginia

  • Study site

    Hanleysville, Pennsylvania

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Hialeah, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntington, West Virginia

  • Study site

    Hutchinson, Kansas

  • Study site

    Hyannis, Massachusetts

  • Study site

    Indianapolis, Indiana

  • Study site

    Inverness, Florida

  • Study site

    Irving, Texas

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jacksonville Beach, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kansas City, Missouri

  • Study site

    Katy, Texas

  • Study site

    Kettering, Ohio

  • Study site

    Kingsport, Tennessee

  • Study site

    La Crosse, Wisconsin

  • Study site

    La Mesa, California

  • Study site

    LaGrange, Illinois

  • Study site

    Laguna Hills, California

  • Study site

    Lakewood, Colorado

  • Study site

    Las Vegas, Nevada

  • Study site

    Laurens, South Carolina

  • Study site

    Layton, Utah

  • Study site

    Lenoir, North Carolina

  • Study site

    Levittown, Pennsylvania

  • Study site

    Lewisburg, West Virginia

  • Study site

    Linden, New Jersey

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Madison, Wisconsin

  • Study site

    Manassas, Virginia

  • Study site

    Marion, Ohio

  • Study site

    Marrero, Louisiana

  • Study site

    Melbourne, Florida

  • Study site

    Miami, Florida

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Midland, Texas

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mine Hill, New Jersey

  • Study site

    Mineola, New York

  • Study site

    Mission Hills, California

  • Study site

    Mobile, Alabama

  • Study site

    Monroe, Louisiana

  • Study site

    Mooresville, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Mount Clemens, Michigan

  • Study site

    Muncie, Indiana

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Nashua, New Hampshire

  • Study site

    Nashville, Tennessee

  • Study site

    Natchitoches, Louisiana

  • Study site

    Natick, Massachusetts

  • Study site

    National City, California

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newport Beach, California

  • Study site

    Newton, Kansas

  • Study site

    Norcross, Georgia

  • Study site

    Norman, Oklahoma

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Miami Beach, Florida

  • Study site

    Novi, Michigan

  • Study site

    Oak Ridge, Tennessee

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Oviedo, Florida

  • Study site

    Paramount, California

  • Study site

    Pawtucket, Rhode Island

  • Study site

    Pearland, Texas

  • Study site

    Pell City, Alabama

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perrysburg, Ohio

  • Study site

    Philadelphi, Pennsylvania

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pismo Beach, California

  • Study site

    Pontiac, Michigan

  • Study site

    Portland, Maine

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Redondo Beach, California

  • Study site

    Rocky Mount, North Carolina

  • Study site

    Roswell, Georgia

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Cloud, Minnesota

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    San Franciso, California

  • Study site

    Sarasota, Florida

  • Study site

    Saratoga Springs, New York

  • Study site

    Scotland, Pennsylvania

  • Study site

    Seaford, Delaware

  • Study site

    Sherveport, Louisiana

  • Study site

    Simpsonville, South Carolina

  • Study site

    Smithtown, New York

  • Study site

    Somerset, New Jersey

  • Study site

    South Plainfield, New Jersey

  • Study site

    Spring, Texas

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Massachusetts

  • Study site

    Springfield, Ohio

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stockton, California

  • Study site

    Suwanee, Georgia

  • Study site

    Syracuse, New York

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Thousand Oaks, California

  • Study site

    Toledo, Ohio

  • Study site

    Tomball, Texas

  • Study site

    Toms Rivers, New Jersey

  • Study site

    Topeka, Kansas

  • Study site

    Torrance, California

  • Study site

    Trinity, Florida

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Tullahoma, Tennessee

  • Study site

    Tulsa, Oklahoma

  • Study site

    Uniontown, Pennsylvania

  • Study site

    Valley Village, California

  • Study site

    Vero Bearch, Florida

  • Study site

    Victoria, Texas

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Waterloo, Iowa

  • Study site

    Wauwatosa, Wisconsin

  • Study site

    Wenatchee, Washington

  • Study site

    Westlake Village, California

  • Study site

    Wichita, Kansas

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Woodstock, Georgia

Other trials in United States

Argentina27 sites

  • Study site

    Bahía Blanca, Buenos Aires

  • Study site

    Buenos Aires, Ciudad Autonoma Buenos Aires

  • Study site

    Cipolletti, Río Negro Province

  • Study site

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires

  • Study site

    Córdoba, Córdoba Province

  • Study site

    Córdoba

  • Study site

    Corrientes, Corrientes Province

  • Study site

    Godoy Cruz, Mendoza Province

  • Study site

    Haedo, Buenos Aires

  • Study site

    La Plata, Buenos Aires

  • Study site

    Loma Hermosa, Buenos Aires

  • Study site

    Mar del Plata, Buenos Aires

  • Study site

    Mendoza, Mendoza Province

  • Study site

    Quilmes, Buenos Aires

  • Study site

    Rosario, Santa Fe Province

  • Study site

    Rosario

  • Study site

    Salta, Salta Province

  • Study site

    San Miguel de Tucumán, Tucumán Province

  • Study site

    San Nicolás de los Arroyos, Buenos Aires

  • Study site

    San Salvador de Jujuy, Jujy

  • Study site

    Santa Fe, Santa Fe Province

  • Study site

    Santiago del Estero, Santiago del Estero Province

  • Study site

    Trelew, Chubut Province

  • Study site

    Venado Tuerto, Santa Fe Province

  • Study site

    Villa Cabrera, Córdoba Province

  • Study site

    Villa María, Córdoba Province

  • Study site

    Zárate, Buenos Aires

Other trials in Argentina

Mexico22 sites

  • Study site

    Acapulco de Juárez, Guerrero

  • Study site

    Aguascalientes, Aguascalientes

  • Study site

    Chihuahua City, Chihuahua

  • Study site

    Cuauhtémoc, Mexico City

  • Study site

    Cuautitlán Izcalli, State of Mexico

  • Study site

    Cuernavaca, Morelos

  • Study site

    Culiacán, Sinaloa

  • Study site

    Durango, Durango

  • Study site

    Guadalajara, Jalisco

  • Study site

    Mérida, Yucatán

  • Study site

    Metepec, State of Mexico

  • Study site

    Mexico City, Mexico City

  • Study site

    Monterrey, Nuevo Le=n

  • Study site

    Monterrey, Nuevo León

  • Study site

    Morelia, Michoacán

  • Study site

    Pachuca, Hidalgo

  • Study site

    San Luis Potosí City, San Luis Potos

  • Study site

    Tamaulipas, Tamaulipas

  • Study site

    Tijuana, Baja California Norte

  • Study site

    Torreón, Coahuila

  • Study site

    Xalapa, Veracruz

  • Study site

    Zapopan, Jalisco

Other trials in Mexico

Australia21 sites

  • Study site

    Adelaide, South Australia

  • Study site

    Brisbane, Queensland

  • Study site

    Bruce, Australian Capital Territory

  • Study site

    Bruce

  • Study site

    Canberra, Australian Capital Territory

  • Study site

    Clayton, Victoria

  • Study site

    Daw Park, South Australia

  • Study site

    Elizabeth Vale, South Australia

  • Study site

    Fitzroy, Victoria

  • Study site

    Garran, Australian Capital Territory

  • Study site

    Garran

  • Study site

    Geelong, Victoria

  • Study site

    Joondalup, Western Australia

  • Study site

    Meadowbrook, Queensland

  • Study site

    Melbourne, Victoria

  • Study site

    Milton, Queensland

  • Study site

    Sale, Victoria

  • Study site

    Townsville, Queensland

  • Study site

    Westmead, New South Wales

  • Study site

    Wollongong, New South Wales

  • Study site

    Woolloongabba, Queensland

Other trials in Australia

Canada21 sites

  • Study site

    Brampton, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Etobicoke, Ontario

  • Study site

    Gatineau, Quebec

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Hamilton, Ontario

  • Study site

    Laval, Quebec

  • Study site

    Longueuil, Quebec

  • Study site

    Markham, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Oakville, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Saint-Jérôme, Quebec

  • Study site

    Saint-Laurent, Quebec

  • Study site

    Spruce Grove, Alberta

  • Study site

    Thornhill, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Victoria, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Hungary20 sites

  • Study site

    Baja

  • Study site

    Balatonfüred

  • Study site

    Budaörs

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Eger

  • Study site

    Gödöllő

  • Study site

    Gyula

  • Study site

    Kecskemét

  • Study site

    Kistelek

  • Study site

    Komárom

  • Study site

    Makó

  • Study site

    Pécs

  • Study site

    Szeged

  • Study site

    Szekszárd

  • Study site

    Szikszó

  • Study site

    Szombathely

  • Study site

    Úrhida

  • Study site

    Veszprém

  • Study site

    Zalaegerszeg

Other trials in Hungary

Poland17 sites

  • Study site

    Bialystok

  • Study site

    Gdansk

  • Study site

    Gliwice

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Kamieniec Ząbkowicki

  • Study site

    Łęczyca

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Oświęcim

  • Study site

    Parczew

  • Study site

    Poznan

  • Study site

    Puławy

  • Study site

    Radom

  • Study site

    Ruda Śląska

  • Study site

    Rzeszów

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

United Kingdom17 sites

  • Study site

    Bexhill-on-Sea, East Sussex

  • Study site

    Cardiff, Cardiff

  • Study site

    Exeter, Devon

  • Study site

    Gillingham, Kent

  • Study site

    Harrow, Middlesex

  • Study site

    Hull, East Riding of Yorkshire

  • Study site

    Leicester, Leicestershire

  • Study site

    Liverpool, Merseyside

  • Study site

    Northwood, Middlesex

  • Study site

    Plymouth, Devon

  • Study site

    Portsmouth, Hampshire

  • Study site

    Stoke-on-Trent, Staffordshire

  • Study site

    Swansea, West Glamorgan

  • Study site

    Thornton-Cleveleys, Lancashire

  • Study site

    Torquay, Devon

  • Study site

    Truro, Cornwall

  • Study site

    Watford, Hertfordshire

Other trials in United Kingdom

Czechia15 sites

  • Study site

    České Budějovice

  • Study site

    Choceň

  • Study site

    Jindřichův Hradec

  • Study site

    Kroměříž

  • Study site

    Mariánské Lázně

  • Study site

    Moravský Krumlov

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Ostrava - Moravska Ostrava

  • Study site

    Ostrava - Vitkovice

  • Study site

    Prague

  • Study site

    Praha 4 - Krc

  • Study site

    Slaný

  • Study site

    Trutnov

  • Study site

    Ústí nad Labem

Other trials in Czechia

Malaysia15 sites

  • Study site

    Alor Star, Kedah

  • Study site

    Ipoh, Perak

  • Study site

    Johor Bahru, Johor

  • Study site

    Kelantan, Kelantan

  • Study site

    Kota Bharu, Kelantan

  • Study site

    Kuala Lumpur, Kuala Lumpur

  • Study site

    Kuala Selangor, Selangor

  • Study site

    Kuala Selangor

  • Study site

    Lembah Pantai, Kuala Lumpur

  • Study site

    Malacca, Melaka

  • Study site

    Petaling Jaya, Selangor

  • Study site

    Taiping, Perak

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About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.

Read the detailed description

The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes. This study will look at the number of cardiovascular events (for example, heart attacks) of people who take TAK-875 in comparison to placebo in addition to standard care.

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.

Being tested
TAK-875, TAK-875 Placebo
Keywords
Drug therapy
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-875Drug

    TAK-875 tablets

  • TAK-875 PlaceboDrug

    TAK-875 placebo-matching tablets

Study groups in NCT01609582
Study groupRoleWhat they receive
TAK-875 50 mgExperimentalTAK-875 50 mg tablets, orally, once daily for up to 6 years.
Receives: Drug: TAK-875
PlaceboPlacebo comparatorTAK-875 placebo-matching tablets, orally, once daily for up to 6 years.
Receives: Drug: TAK-875 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite

    The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).

    Measured: Baseline up to end of study (up to Day 588)

Secondary outcomes (1)

  1. Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite

    The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke.

    Measured: Baseline up to end of study (up to Day 588)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionMay 2014
  4. Study completionMay 2014

Why it stopped: Due to potential concerns about liver safety (See Detailed Description)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01609582
Sponsor's protocol ID
TAK-875_306
Other IDs
2011-001732-37, U1111-1129-7824, TAK-875_306CTIL, DOH-27-0313-4117, 12/SC/0504, NMRR-12-433-12087, PHRR130916-000119, 1015031332
Status last verified
Oct 2015
First submitted
29 May 2012
Last updated
19 Oct 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30880443

  • 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.

    PubMed 30459247

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-875 in people with Type 2 Diabetes and Cardiovascular Disease, run by Takeda at 584 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 584 sites in United States, Argentina, Mexico, Australia, Canada and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite (time frame: Baseline up to end of study (up to Day 588)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01609582, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.

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