Sitagliptin Prospective study of Intima media thickness Evaluation Extension Study - SPIKE Extension Study

Japan Cardiovascular Research foundation0 个研究点目标入组 274 人开始时间: 2014年5月20日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients with type 1 or secondary diabetes 2) Patients with severe infections, pre-/post-operative status, and serious injuries 3) Patients with previous events of myocardial infarction, angina pectoris, stroke, or cerebral infarction 4) Patients complicated with diabetic retinopathy requiring retinal photocoagulation or crystalline lens surgery, or those who have undergone these treatments within the last one year 5) Patients with moderate or more severe renal dysfunction (serum creatinine [mg/dL] > 1.4 [male] or > 1.2 [female]) 6) Patients with severe liver dysfunction (AST: 100 IU/l or above) 7) Patients with moderate or more severe heart failure (NYHA [New York Heart Association] class of III or above) 8) Patients prescribed other incretin-based agents, including DPP-4 inhibitors, at study initiation 9) Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at study initiation 10) Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant 11) Patients with previous hypersensitivity to the investigated drug 12) Other patients determined ineligible by an investigator

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