Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: TAK-875; TAK-875 Placebo
Intervention description: TAK-875 tablets; TAK-875 placebo-matching tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 393.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific
      adults with type 2 diabetes mellitus (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the patient is capable of understanding and
             complying with protocol requirements.

          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. Male or female, aged at least 18 years or over the legal age of consent in countries
             where that is greater than 18 years, with a historical diagnosis of T2DM.

          4. Has an HbA1c of 7.0% to 10.0%, inclusive at screening, and has been treated with diet
             and exercise for at least 3 months.

          5. Has a body mass index (BMI) of ≤45 kg/m^2 at screening.

          6. Patients regularly using, non-excluded medications, must be on a stable dose for at
             least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or
             over-the-counter medication is allowed at the discretion of the investigator.

          7. A female of childbearing potential who is sexually active with a nonsterilized male
             partner agrees to routinely use adequate contraception from signing of the informed
             consent throughout the duration of the study and for 30 days after the last dose of
             study drug.

          8. Is able and willing to monitor glucose with a home glucose monitor and consistently
             record his or her own blood glucose concentrations and complete subject diaries.

        Exclusion Criteria:

          1. Is unable to understand the official language (verbal or written) of the country for
             which a certified translation of the approved informed consent is available.

          2. 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 (eg, spouse,
             parent, child, or sibling; biological or legally adopted) or may consent under duress.

          3. Has hemoglobin a level ≤12 g/dL (≤120 g/L) (males) and ≤10 g/dL (≤100 g/L) (females)
             at the Screening Visit.

          4. Has a history of any hemoglobinopathy that may affect determination of HbA1c.

          5. Donated or received any blood products within 12 weeks prior to Screening or is
             planning to donate blood during the study.

          6. Has systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening or
             Baseline (If the patient meets this exclusion criterion, the assessment may be
             repeated once at least 30 minutes after initial measurement and decision will be made
             based on the second measurement).

          7. Had coronary angioplasty, coronary stent placement, coronary bypass surgery,
             myocardial infarction, unstable angina pectoris, clinically significant abnormal
             electrocardiogram, cerebrovascular accident or transient ischemic attack within 3
             months prior or at Screening.

          8. Has a serum creatinine level of ≥1.5 mg/dL (males) and ≥1.4 mg/dL (females) and/or
             estimated glomerular filtration rate (GFR) <60 mL/min/1.73m^2 at Screening.

          9. Has uncontrolled thyroid disease.

         10. Has a history of laser treatment for proliferative diabetic retinopathy within 6
             months prior to Screening.

         11. Has a history or treatment for diabetic gastric paresis, gastric banding, or gastric
             bypass surgery.

         12. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels
             >2.0x the upper limit of normal range (ULN) at Screening.

         13. Has a total bilirubin level greater than the ULN at Screening. Exception: if a patient
             has documented Gilbert's Syndrome, they will be allowed with an elevated bilirubin
             level per the investigator's discretion.

         14. Has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B
             virus (HBV), or Hepatitis C virus (HCV).

         15. If a patient has no known history of HBV infection, then a HBV Screening test panel
             should be done. If the test is positive and there is clinical manifestation of active
             infection per Investigator's diagnosis, then the patient should be excluded. In
             addition, if the patient is considered to need antiviral treatment, the patient should
             be excluded. (If the test results indicate only an hepatitis B surface antigen (HBsAg)
             carrier without any clinical manifestation of active infection, and no antiviral
             treatment is needed, then the patient could be enrolled provided all other criteria
             are met.)

         16. 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.

         17. Has received any investigational compound within 30 days prior to Screening or has
             received >7 days of any antidiabetic agent within 3 months prior to Screening.

         18. Has received TAK-875 in a previous clinical study.

         19. Has a history of hypersensitivity, allergies or has had an anaphylactic reaction(s) to
             any component of TAK-875.

         20. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol
             abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per
             day) within 2 years prior to Screening.

         21. Received excluded medications prior to Screening or is expected to receive excluded
             medications.

         22. If female, is pregnant (confirmed by laboratory testing, ie, serum/urine 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.

         23. If male, intends to donate sperm during the course of this study or for 30 days after
             final study medication dose.

         24. 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 subject according to the protocol.