Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes

Exclusion Criteria

• •1. The participant has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
• •2. The participant has been randomized in a previous TAK-875 study.
• •3. The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
• •4. The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
• •5. The participant has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
• •6. The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Screening (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).
• •7. The participant 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.
• •8. The participant has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0x the upper limit of normal (ULN) at Screening.
• •9. The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
• •10. The participant has a serum creatinine ≥1.5 mg/dL(≥133 µmol/L) \[males\] and ≥1.4 mg/dL (≥124 µmol/L) \[females\] and/or estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m\^2 at Screening.
• •11. The participant has uncontrolled thyroid disease.
• •12. The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• •13. The participant has had gastric banding or gastric bypass surgery within one year prior to Screening.
• •14. The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
• •15. The participant had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.
• •16. The participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875.
• •17. The participant has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
• •18. The participant received excluded medications prior to Screening or is expected to receive excluded medication.
• •19. If female, the participant is pregnant (confirmed by laboratory testing, i.e., serum human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
• •20. The participant is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
• •21. The participant has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the participant according to the protocol.
• •1. The participant received excluded medications during the Placebo Run-in Period. (Topical and inhaled corticosteroids are allowed).
• •2. The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Baseline (Visit 4) (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).