Clinical trial NCT01609582: Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Cardiovascular Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 3207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite
timeFrame: Baseline up to end of study (up to Day 588)
Secondary outcomes:
measure: Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite
timeFrame: Baseline up to end of study (up to Day 588)
Other outcomes:
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city: Newton
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city: Topeka
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city: Elizabethtown
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city: Marrero
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city: Monroe
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city: Natchitoches
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city: New Orleans
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city: Sherveport
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city: Annapolis
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city: Hyannis
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city: Natick
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city: Cadillac
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city: Flint
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city: Kalamazoo
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city: Mt. Clemens
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city: Pontiac
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city: Saginaw
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city: St. Cloud
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city: St. Paul
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city: Columbia
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state: Missouri
city: Kansas City
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city: St. Louis
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city: Las Vegas
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city: Nashua
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city: Bridgewater
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city: Elizabeth
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city: Mine Hill
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state: New Mexico
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city: Buffalo
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city: Mineola
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city: Saratoga Springs
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city: Smithtown
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state: New York
city: Syracuse
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city: Burlington
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state: North Carolina
city: Calabash
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Durham
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state: North Carolina
city: Greensboro
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city: Hickory
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city: Mooresville
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city: Morganton
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city: Raleigh
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city: Canton
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city: Cincinnati
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city: Cleveland
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city: Columbus
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city: Kettering
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city: Marion
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city: Springfield
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state: Ohio
city: Norman
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state: Oklahoma
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city: Portland
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state: Oregon
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state: Pennsylvania
city: Hanleysville
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state: Pennsylvania
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state: Pennsylvania
city: Levittown
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state: Pennsylvania
city: Norristown
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state: Pennsylvania
city: Philadelphia
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city: Philadelphi
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state: Pennsylvania
city: Scotland
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state: Pennsylvania
city: Uniontown
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state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Pawtucket
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state: Rhode Island
city: Columbia
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state: South Carolina
city: Greer
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state: South Carolina
city: Laurens
country: United States
state: South Carolina
city: Simpsonville
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state: South Carolina
city: Bristol
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state: Tennessee
city: Crossville
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state: Tennessee
city: Jackson
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state: Tennessee
city: Kingsport
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state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Oak Ridge
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state: Tennessee
city: Tullahoma
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state: Tennessee
city: Austin
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state: Texas
city: Carrollton
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state: Texas
city: Dallas
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state: Texas
city: Fort Worth
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state: Texas
city: Houston
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city: Irving
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state: Texas
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city: Midland
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state: Texas
city: Odessa
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state: Texas
city: Pearland
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state: Texas
city: San Antonio
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state: Texas
city: Spring
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city: Tomball
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state: Texas
city: Victoria
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state: Texas
city: Bountiful
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state: Utah
city: Layton
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state: Utah
city: Salt Lake City
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state: Utah
city: Alexandria
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state: Virginia
city: Danville
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state: Virginia
city: Falls Church
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state: Virginia
city: Hampton
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state: Virginia
city: Manassas
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state: Virginia
city: Wenatchee
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state: Washington
city: Huntington
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state: West Virginia
city: Lewisburg
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state: West Virginia
city: La Crosse
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state: Wisconsin
city: Madison
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state: Wisconsin
city: Milwaukee
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state: Wisconsin
city: Wauwatosa
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state: Wisconsin
city: Bahia Blanca
country: Argentina
state: Buenos Aires
city: Haedo
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: Loma Hermosa
country: Argentina
state: Buenos Aires
city: Mar del Plata
country: Argentina
state: Buenos Aires
city: Quilmes
country: Argentina
state: Buenos Aires
city: San Nicolas
country: Argentina
state: Buenos Aires
city: Zarate
country: Argentina
state: Buenos Aires
city: Trelew
country: Argentina
state: Chubut
city: Ciudad Autonoma de Buenos Aires
country: Argentina
state: Ciudad Autonoma Buenos Aires
city: Córdoba
country: Argentina
state: Cordoba
city: Villa Cabrera
country: Argentina
state: Cordoba
city: Villa Maria
country: Argentina
state: Cordoba
city: San Salvador de Jujuy
country: Argentina
state: Jujy
city: Godoy Cruz
country: Argentina
state: Mendoza
city: Cipolletti
country: Argentina
state: Rio Negro
city: Rosario
country: Argentina
state: Santa Fe
city: Venado Tuerto
country: Argentina
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Corrientes
country: Argentina
city: Mendoza
country: Argentina
city: Rosario
country: Argentina
city: Salta
country: Argentina
city: Santa Fe
country: Argentina
city: Santiago del estero
country: Argentina
city: Bruce
country: Australia
state: Australian Capital Territory
city: Canberra
country: Australia
state: Australian Capital Territory
city: Garran
country: Australia
state: Australian Capital Territory
city: Westmead
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Meadowbrook
country: Australia
state: Queensland
city: Milton
country: Australia
state: Queensland
city: Townsville
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Daw Park
country: Australia
state: South Australia
city: Elizabeth Vale
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Sale
country: Australia
state: Victoria
city: Joondalup
country: Australia
state: Western Australia
city: Bruce
country: Australia
city: Garran
country: Australia
city: Fortaleza
country: Brazil
state: Ceará
city: Brasilia
country: Brazil
state: Distrito Federal
city: Goiania
country: Brazil
state: Goiás
city: Campina Grande do Sul
country: Brazil
state: Paraná
city: Curitiba
country: Brazil
state: Paraná
city: Belem
country: Brazil
state: Pará
city: Recife
country: Brazil
state: Pernambuco
city: Canoas
country: Brazil
state: Rio Grande do Sul
city: Caxias do Sul
country: Brazil
state: Rio Grande do Sul
city: Passo Fundo
country: Brazil
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Santa Maria
country: Brazil
state: Rio Grande do Sul
city: Marilia
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: Sao Paulo
country: Brazil
city: Blagoevgrad
country: Bulgaria
city: Byala
country: Bulgaria
city: Kazanlak
country: Bulgaria
city: Pazardzhik
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sevlievo
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Spruce Grove
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Brampton
country: Canada
state: Ontario
city: Etobicoke
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Thornhill
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Gatineau
country: Canada
state: Quebec
city: Laval
country: Canada
state: Quebec
city: Longueuil
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe Claire
country: Canada
state: Quebec
city: St-Jérôme
country: Canada
state: Quebec
city: Ville Saint-Laurent
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Cakovec
country: Croatia
city: Karlovac
country: Croatia
city: Koprivnica
country: Croatia
city: Krapinske Toplice
country: Croatia
city: Osijek
country: Croatia
city: Rijeka
country: Croatia
city: Sisak
country: Croatia
city: Slavonski Brod
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city: Virovitica
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city: Zadar
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city: Zagreb
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city: Ceske Budejovice
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city: Chocen
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city: Jindrichuv Hradec
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city: Kromeriz
country: Czech Republic
city: Marianske Lazne
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city: Moravsky Krumlov
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava - Moravska Ostrava
country: Czech Republic
city: Ostrava - Vitkovice
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Prague 10
country: Czech Republic
city: Praha 4 - Krc
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Slany
country: Czech Republic
city: Trutnov
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Paide
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city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Corbeil Essonnes
country: France
state: Essonne
city: Corbeil Essonne
country: France
state: Essonne
city: Pessac
country: France
state: Gironde
city: Nanterre cedex
country: France
state: Hauts de Seine
city: Nantes cedex 01
country: France
state: Loire Atlantique
city: Pierre-Bénite cedex
country: France
state: Rhone
city: Paris
country: France
city: Friedrichsthal
country: Germany
state: Baden Wuerttemberg
city: Falkensee
country: Germany
state: Brandenburg
city: Kelkheim
country: Germany
state: Hessen
city: Dortmund
country: Germany
state: Nordrhein Westfalen
city: Essen
country: Germany
state: Nordrhein Westfalen
city: Goch
country: Germany
state: Nordrhein Westfalen
city: Kamp-Lintfort
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state: Nordrhein Westfalen
city: Koeln
country: Germany
state: Nordrhein Westfalen
city: Bad Kreuznach
country: Germany
state: Rheinland Pfalz
city: Hohenmoelsen
country: Germany
state: Sachsen Anhalt
city: Dippoldiswalde
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hong Kong
country: Hong Kong
city: New Territories
country: Hong Kong
city: Baja
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city: Balatonfured
country: Hungary
city: Budaors
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Godollo
country: Hungary
city: Gyula
country: Hungary
city: Kecskemet
country: Hungary
city: Kistelek
country: Hungary
city: Komarom
country: Hungary
city: Mako
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
country: Hungary
city: Szikszo
country: Hungary
city: Szombathely
country: Hungary
city: Urhida
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Ashkelon
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city: Beer Sheva
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city: Beer Yaakov
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city: Beer-Sheva
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city: Givataim
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city: Hadera
country: Israel
city: Haifa
country: Israel
city: Holon
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city: Jerusalem
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city: Kfar-Saba
country: Israel
city: Petach Tikva
country: Israel
city: Petach Tikwa
country: Israel
city: Raanana
country: Israel
city: Tel Aviv
country: Israel
city: Zefat
country: Israel
city: San Donato Milanese
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state: Milano
city: Sesto San Giovanni
country: Italy
state: Milano
city: Firenze
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Wonju-Si
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state: Gangwon-do
city: Seongnam-si
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state: Gyeonggi-do
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state: Gyeongsangnam-do
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state: Kelantan
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state: Distrito Federal
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city: Sahy
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city: Svidnik
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city: Trencin
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city: Zilina
country: Slovakia
city: Port Elizabeth
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state: Eastern Cape
city: Bloemfontein
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state: Free State
city: Johannesburg
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state: Gauteng
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country: South Africa
state: Gauteng
city: Krugersdorp
country: South Africa
state: Gauteng
city: Lenasia
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Durban
country: South Africa
state: KwaZulu-Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Stellenbosch
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Douliou City
country: Taiwan
city: Kaohsiung
country: Taiwan
city: New Taipei City
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkoknoi
country: Thailand
state: Bangkok
city: Dusit
country: Thailand
state: Bangkok
city: Patumwan
country: Thailand
state: Bangkok
city: Rachathevi
country: Thailand
state: Bangkok
city: Rajtevi
country: Thailand
state: Bangkok
city: Ratchathewi
country: Thailand
state: Bangkok
city: Muang
country: Thailand
state: Chiang Mai
city: Muang
country: Thailand
state: Chiang Rai
city: Muang
country: Thailand
state: Khon Kaen
city: Muang
country: Thailand
state: Nakhon Ratchasima
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lugansk
country: Ukraine
city: Mykolayiv
country: Ukraine
city: Odesa
country: Ukraine
city: Poltava
country: Ukraine
city: Simferopol
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnycia
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Truro
country: United Kingdom
state: Cornwall
city: Exeter
country: United Kingdom
state: Devon
city: Plymouth
country: United Kingdom
state: Devon
city: Torquay
country: United Kingdom
state: Devon
city: Hull
country: United Kingdom
state: East Riding of Yorkshire
city: Bexhill on Sea
country: United Kingdom
state: East Sussex
city: Portsmouth
country: United Kingdom
state: Hampshire
city: Watford
country: United Kingdom
state: Hertfordshire
city: Gillingham
country: United Kingdom
state: Kent
city: Thornton-Cleveleys
country: United Kingdom
state: Lancashire
city: Leicester
country: United Kingdom
state: Leicestershire
city: Liverpool
country: United Kingdom
state: Merseyside
city: Harrow
country: United Kingdom
state: Middlesex
city: Northwood
country: United Kingdom
state: Middlesex
city: Stoke on Trent
country: United Kingdom
state: Staffordshire
city: Swansea
country: United Kingdom
state: West Glamorgan
city: Cardiff
country: United Kingdom
Study officials:
affiliation: Takeda
name: Sr. Medical Director Clinical Science
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.