Prospective and randomized controlled study on the efficacy and safety of ipragliflozin and metformin to visceral fat reduction for the patients being treated with DPP-4 inhibitors for poor glycemic controlled type-2 diabetes - PRIME-V Study

Chiba University Hospital0 个研究点目标入组 106 人开始时间: 2014年9月21日最近更新: 2023年10月17日

适应症

试验速览

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•(1) Type 1 Diabetes (2) Patients who have experienced metabolic acidosis, diabetic coma and/or pre-coma within six months prior to providing consent (3) Serious infections requiring insulin treatment, prior/upcoming surgeries, and/or severe injuries. (4) Patients with considerable loss of kidney function (creatine blood level of over 1.3mg/dL in men, and over 1.2mg/dL in women) and/or undergoing dialysis (including peritoneal dialysis) (5) Serious liver damage (6) History of stroke, myocardial infarction, heart failure as well as other severe cardiovascular complications requiring hospitalization (7) Patient is taking oral hypoglycemic agents other than DPP-4 inhibitors at the start of the trial. (8) Women who are pregnant or nursing, or could become pregnant (9) History of chemical sensitivity to DPP-4 inhibitors, SGLT2 inhibitors, and/or metformin (10) Suffering or at risk from urinary tract infection and/or dehydration (11) Tested positive for Ketone bodies (12) History of lactic acidosis (13) Excessive alcohol consumption (14) History of osteoporosis (15) Patients who have undergone a CT scan within 3 months prior to providing written consent (16) Determined to be ineligible by the physician in charge for any other reason

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