| Outcome Measures: |
Primary: Change from baseline in glycosylated hemoglobin., Week 12 or Final Visit.. | Secondary: Change from baseline in glycosylated hemoglobin., Weeks 4, 8 and 12 or Final Visit.|Change from baseline in fasting plasma glucose., Weeks: 1, 2, 4, 8 and 12 or Final Visit.|Change from baseline in 1,5 anhydroglucitol., Weeks 2, 4, 8 and 12 or Final Visit.|Change from baseline in proinsulin., Weeks 4, 8 and 12 or Final Visit.|Change from baseline in insulin., Weeks 4, 8 and 12 or Final Visit.|Change from baseline in proinsulin/insulin ratio., Weeks 4, 8 and 12 or Final Visit.|Change from baseline in C-peptide., Weeks 4, 8 and 12 or Final Visit.|Homeostasis model assessment insulin resistance., Weeks 4, 8 and 12 or Final Visit.|Homeostasis model assessment beta-cell function., Weeks 4, 8 and 12 or Final Visit.|Incidence of marked hyperglycemia (fasting plasma glucose ≥200 mg/dL [≥11.10 mmol/L])., Weeks 1, 2, 4, 8 and 12 or Final Visit.|Incidence of rescue., Weeks 1, 2, 4, 8 and 12 or Final Visit.|Clinical response endpoint incidence of glycosylated hemoglobin ≤6.5%., Week 12 or Final Visit.|Clinical response endpoint incidence of glycosylated hemoglobin ≤7.0%., Week 12 or Final Visit.|Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥1.0%., Week 12 or Final Visit.|Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥1.5%., Week 12 or Final Visit.|Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥2.0%., Week 12 or Final Visit.|Fasting lipids (triglycerides, total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol)., Weeks 4, 8, and 12 or Final Visit.|Postprandial area under the concentration-time curve and peak 2-hour values of plasma glucose, insulin and C-peptide during a 3-hour mixed-meal tolerance test in a subset of subjects., Week 12 or Final Visit.|Plasma concentration of SYR-619., Week 8.|Physical examination findings (including a clinical examination of skin and digits)., At All Visits|Vital sign measurements., At All Visits|Body temperature measurements., Week 12 or Final Visit.|12-lead electrocardiogram tracings., Week 12 or Final Visit.|Incidence of adverse events., At All Visits|Incidence of hypoglycemia (blood glucose <60 mg/dL [<3.33 mmol/L]) in the presence of symptoms or blood glucose <50 mg/dL [<2.78 mmol/L]) regardless of symptoms)., At All Visits|Clinical laboratory evaluations (hematology and serum chemistry)., At All Visits|Clinical laboratory evaluation (urinalysis)., Week 12 or Final Visit.
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