Effect of SYR-472 on Cardiac Function in Healthy Adults

Type 2 diabetes mellitus is a complex metabolic disorder characterized by abnormal insulin secretion and an abnormal glucose balance. The primary risk factor for developing type 2 diabetes mellitus is obesity, which can result in insulin resistance in the body. Insulin resistance is characterized by an impaired response to the physiologic effects of insulin, and leads to decreased cellular glucose uptake, increased hepatic gluconeogenesis and a compensatory increase in insulin secretion that contributes to beta-cell exhaustion. SYR-472 is being developed by Takeda Pharmaceutical Company Ltd. as an adjunct to diet and exercise to treat patients with type 2 diabetes mellitus. Medicinal products that prolong cardiac repolarization have been associated with a specific, potentially fatal polymorphic ventricular tachycardia called torsade de pointes. Although no evidence of cardiovascular effects have been noted in non-clinical studies of SYR-472 nor treatment-related trends revealed in phase 1 studies of SYR-472, this study is being conducted to investigate the effect of SYR-472 on electrocardiography in healthy adults, in compliance with the International Conference of Harmonization Tripartite Guideline: The clinical evaluation of QT/QTc (QT interval corrected for heart rate ) interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (ICH E14).