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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01609582




Registration number
NCT01609582
Ethics application status
Date submitted
29/05/2012
Date registered
1/06/2012
Date last updated
19/10/2015

Titles & IDs
Public title
Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
Scientific 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
Secondary ID [1] 0 0
2011-001732-37
Secondary ID [2] 0 0
TAK-875_306
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-875
Treatment: Drugs - TAK-875 Placebo

Experimental: TAK-875 50 mg - TAK-875 50 mg tablets, orally, once daily for up to 6 years.

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


Treatment: Drugs: TAK-875
TAK-875 tablets

Treatment: Drugs: TAK-875 Placebo
TAK-875 placebo-matching tablets

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Baseline up to end of study (up to Day 588)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline up to end of study (up to Day 588)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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- Bruce
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- Canberra
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- Westmead
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- Wollongong
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- Brisbane
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- Meadowbrook
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- Milton
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- Townsville
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- Woolloongabba
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- Adelaide
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- Daw Park
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- Elizabeth Vale
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- Clayton
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- Fitzroy
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- Geelong
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- Melbourne
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- Sale
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- Joondalup
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- Brisbane
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- Meadowbrook
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- Milton
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- Townsville
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- Woolloongabba
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- Adelaide
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- Daw Park
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- Elizabeth Vale
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- Clayton
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- Fitzroy
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- Geelong
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- Melbourne
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- Sale
Recruitment postcode(s) [19] 0 0
- Joondalup
Recruitment outside Australia
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Berlin
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Baja
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Budaors
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Budapest
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Eger
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Godollo
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Gyula
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Kistelek
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Mako
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Pecs
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Szeged
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Hungary
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Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01609582
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Medical Director Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01609582