Efficacy and Safety Study of SYR-619 in Treating Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria

• •Male or female, with a historical diagnosis of type 2 diabetes mellitus.
• •Treatment for diabetes with either lifestyle modification or metformin or sulfonylurea alone for at least the 2 months prior to Screening; and a stable dose of either metformin or sulfonylurea for at least 12 weeks prior to randomization for subjects receiving metformin or sulfonylurea at Screening.
• •Those subjects receiving metformin or sulfonylurea monotherapy at randomization must have been at least 75% compliant with their metformin or sulfonylurea regimen during the run in/stabilization period, as assessed by subject diary and investigator assessment.
• •No treatment with antidiabetic agents other than metformin alone or sulfonylurea alone within the 3 months prior to Screening.
• •Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, and a fasting plasma glucose \<275 mg/dL (\<15.27 mmol/L) at the Week -1 visit.
• •Body mass index ≥23 and ≤45 kg/m2.
• •Fasting C-peptide concentration ≥0.8 ng/mL (≥0.26 nmol/L). (If this screening criterion is not met, the subject still qualifies if C-peptide ≥1.5 ng/mL \[≥0.50 nmol/L\] after a challenge test).
• •If regular use of other non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
• •Systolic blood pressure \<160 mm Hg and diastolic pressure \<100 mm Hg.
• •Hemoglobin ≥12 g/dL (≥120 gm/L) for males and ≥10 g/dL (≥100 gm/L) for females.
• •Alanine aminotransferase ≤3 x upper limit of normal.
• •Serum creatinine \<1.5 mg/dL (\<133 micromol/L) for males and \<1.4 mg/dL (\<124 micromol/L) for females.
• •Urine albumin/creatinine ratio of \<1000 μg/mg (113 mg/mol) at Screening. If elevated, the subject may be rescreened within 1 week.
• •Thyroid-stimulating hormone level ≤ the upper limit of the normal range and the subject has normal thyroid function (clinically euthyroid)
• •A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be neither pregnant nor lactating from Screening and throughout the duration of the study.
• •Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
• •No major illness or debility that in the investigator's opinion prohibits the subject from completing the study.