Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: TAK-875; TAK-875 Placebo; Glimepiride
Intervention description: TAK-875 50 mg tablets; TAK-875 placebo-matching tablets; Glimepiride tablet.
Intervention MeSH terms: Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of TAK-875 compared to placebo on
      glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in
      addition to diet and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant or, when applicable, the participant'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 and aged 18 or older with a historical diagnosis of type 2 diabetes
             mellitus (T2DM).

          4. Has a glycosylated hemoglobin (HbA1c) of 7.0% to10.0%, inclusive at screening, and has
             been treated with diet and exercise and a sulfonylurea for at least 12 weeks.

          5. Has a body mass index (BMI) ≤45 kg/m2 at Screening.

          6. Participants regularly using other, non-excluded medications, must be on a stable dose
             and regimen for at least 4 weeks prior to Screening. However, as needed (PRN) use of
             prescription or over-the-counter medication is allowed at the discretion of the
             investigator. Note: Participants who require initiation of a chronically administered
             medication(s) due to a disease or condition diagnosed at Screening must be re-screened
             after the new regimen has been stabilized.

          7. A female of childbearing potential who is sexually active with a non-sterilized male
             partner agrees to use routinely 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. Is able and willing to monitor glucose with a sponsor-provided home glucose monitor
             and consistently record his or her own blood glucose concentrations and participant
             diaries.

        Exclusion Criteria:

          1. 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. Has participated in 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, child, sibling) or may consent under duress.

          4. Has donated or received any blood products within 12 weeks prior to Screening or is
             planning to donate blood during the study.

          5. Has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females
             at Screening.

          6. 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. 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. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels
             >2.0x the upper limit of normal (ULN) at Screening.

          9. 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. Has a serum creatinine ≥1.5 mg/dL (≥133 μmol/L) [if male] or ≥1.4 mg/dL (≥124 μmol/L)
             [if female] and/or estimated (based on Modification of Diet in Renal Disease [MDRD]
             calculation) glomerular filtration rate (GFR) <60 mL/min/1.73m2 (regardless of gender)
             at Screening.

         11. Has uncontrolled thyroid disease.

         12. Has a history of laser treatment for proliferative diabetic retinopathy within 6
             months prior to Screening.

         13. Has had gastric banding or gastric bypass surgery within 1 year prior to Screening.

         14. Has known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency, which
             increases risk for hemolytic anemia by sulfonylurea treatment.

         15. Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B
             virus (HBV), or hepatitis C virus (HCV).

         16. 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.

         17. Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s)
             to any component of TAK-875 or glimepiride.

         18. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol
             abuse within 2 years prior to Screening.

         19. Received excluded medications prior to Screening or is expected to receive excluded
             medication.

         20. If female, the participant is pregnant (confirmed by laboratory testing, ie, 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.

         21. Is unable to understand verbal or written English or any other language for which a
             certified translation of the approved informed consent is available.

         22. 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.