Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes
Condition: Glycemic Control
Intervention: Fasiglifam (TAK-875); Sitagliptin; Placebo
Intervention description: Fasiglifam (TAK-875) tablets; Sitagliptin tablets; Placebo-matching tablets
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 916.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50
      mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus
      metformin on lowering blood sugar.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant is male or female and 18 years of age or older with a historical
             diagnosis of type II diabetes mellitus.

          2. The participant meets one of the following criteria:

               1. The participant has an HbA1c level ≥7.5 and <10.5%, and has been on a stable
                  daily dose of ≥1500 mg (or documented maximum tolerated dose [MTD]) of metformin
                  for at least 2 months prior to Screening. This participant will immediately enter
                  the Placebo Run-in Period according to Study Schedule A, or;

               2. The participant has an HbA1c level ≥7.5 and <10.5%, and has been on a stable
                  daily dose of <1500 mg of metformin without documented MTD for at least 2 months
                  prior to Screening. After completing the Screening Visit, this participant will
                  have their metformin dose immediately increased to ≥1500 mg (or MTD) for an
                  8-week Titration Period according to Study Schedule B. Following this 8-week
                  period, the participant must qualify for entry into the Placebo Run-in Period by
                  completing the Week -3 procedures including having an HbA1c level ≥7.5 and
                  <10.5%.

          3. The participant has had no treatment with antidiabetic agents other than metformin
             within 2 months prior to Screening (Exception: if a participant has received other
             antidiabetic therapy for ≤7 days within the 2 months prior to Screening).

          4. The participant has a body mass index (BMI) ≤45 kg/m² at Screening.

          5. Participants regularly using other, 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 medications is allowed at the discretion of the investigator.

          6. The participant 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. The participant donated or received any blood products within 12 weeks prior to
             Screening or is planning to donate blood during the study.

          2. Hemoglobin ≤12 g/dL (≤120 g/L) for males and ≤10 g/dL (≤100 g/L) for females at
             Screening Visit.

          3. The participant has systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg
             at Screening Visit. (If the participant meets this exclusion criterion, the assessment
             may be repeated once at least 30 minutes after the initial measurement.)

          4. The participant has a history of laser treatment for proliferative diabetic
             retinopathy within 6 months prior to Screening.

          5. The participant has had treatment for gastric banding or gastric bypass surgery within
             one year prior to Screening.

          6. The participant had coronary angioplasty, coronary stent placement, coronary bypass
             surgery, myocardial infarction, unstable angina pectoris, clinically significant
             abnormal ECG, cerebrovascular accident or transient ischemic attack within 3 months
             prior to or at Screening.