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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01609582
Recruitment Status : Terminated (Due to potential concerns about liver safety (See Detailed Description))
First Posted : June 1, 2012
Results First Posted : August 21, 2015
Last Update Posted : October 19, 2015
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Cardiovascular Disease Drug: TAK-875 Drug: TAK-875 Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TAK-875 50 mg
TAK-875 50 mg tablets, orally, once daily for up to 6 years.
Drug: TAK-875
TAK-875 tablets

Placebo Comparator: Placebo
TAK-875 placebo-matching tablets, orally, once daily for up to 6 years.
Drug: TAK-875 Placebo
TAK-875 placebo-matching tablets

Primary Outcome Measures :
  1. 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) ]
    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).

Secondary Outcome Measures :
  1. Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite [ Time Frame: Baseline up to end of study (up to Day 588) ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
  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.

Exclusion Criteria:

  1. 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.
  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.
  6. 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).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01609582

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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, Philippines
Taytay, Philippines
Bialystok, Poland
Gdansk, Poland
Gliwice, Poland
Grodzisk Mazowiecki, Poland
Kamieniec Zabkowicki, Poland
Leczyca, Poland
Lodz, Poland
Lublin, Poland
Oswiecim, Poland
Parczew, Poland
Poznan, Poland
Pulawy, Poland
Radom, Poland
Ruda Slaska, Poland
Rzeszow, Poland
Warszawa, Poland
Wroclaw, Poland
Bacau, Romania
Baia Mare, Romania
Brasov, Romania
Bucuresti, Romania
Galati, Romania
Iasi, Romania
Oradea, Romania
Ploiesti, Romania
Targu Mures, Romania
Timisoara, Romania
Russian Federation
Arkhangelsk, Russian Federation
Barnaul, Russian Federation
Kazan, Russian Federation
Kemerovo, Russian Federation
Moscow, Russian Federation
Nizhniy Novgorod, Russian Federation
Novosibirsk, Russian Federation
Pushkin, Russian Federation
Saratov, Russian Federation
St. Petersburg, Russian Federation
Yaroslavl, Russian Federation
Bratislava, Slovakia
Komarno, Slovakia
Kosice, Slovakia
Levice, Slovakia
Lucenec, Slovakia
Martin, Slovakia
Nitra, Slovakia
Nove Mesto nad Vahom, Slovakia
Presov, Slovakia
Sahy, Slovakia
Svidnik, Slovakia
Trencin, Slovakia
Zilina, Slovakia
South Africa
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
Douliou City, Taiwan
Kaohsiung, Taiwan
New Taipei City, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Bangkoknoi, Bangkok, Thailand
Dusit, Bangkok, Thailand
Patumwan, Bangkok, Thailand
Rachathevi, Bangkok, Thailand
Rajtevi, Bangkok, Thailand
Ratchathewi, Bangkok, Thailand
Muang, Chiang Mai, Thailand
Muang, Chiang Rai, Thailand
Muang, Khon Kaen, Thailand
Muang, Nakhon Ratchasima, Thailand
Donetsk, Ukraine
Kharkiv, Ukraine
Kyiv, Ukraine
Lugansk, Ukraine
Mykolayiv, Ukraine
Odesa, Ukraine
Poltava, Ukraine
Simferopol, Ukraine
Ternopil, Ukraine
Vinnycia, Ukraine
Vinnytsia, Ukraine
Zaporizhzhia, Ukraine
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
Cardiff, United Kingdom
Sponsors and Collaborators
Study Director: Sr. Medical Director Clinical Science Takeda

Responsible Party: Takeda Identifier: NCT01609582     History of Changes
Other Study ID Numbers: TAK-875_306
2011-001732-37 ( EudraCT Number )
U1111-1129-7824 ( Registry Identifier: WHO )
TAK-875_306CTIL ( Registry Identifier: Israel MOH )
DOH-27-0313-4117 ( Registry Identifier: SANCTR )
12/SC/0504 ( Registry Identifier: NRES )
NMRR-12-433-12087 ( Registry Identifier: NMRR (Malaysia) )
PHRR130916-000119 ( Registry Identifier: PHRR (Philippines) )
1015031332 ( Registry Identifier: TCTIN )
First Posted: June 1, 2012    Key Record Dates
Results First Posted: August 21, 2015
Last Update Posted: October 19, 2015
Last Verified: October 2015

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases