Effect of canagliflozin in type 2 diabetic patients with microalbuminuria in Japanese population - CANPIONE study

Miyamoto Satoshi0 个研究点目标入组 110 人开始时间: 2019年3月12日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•1. Man or woman with a diagnosis of type 2 diabetes
•2. Age >= 20 to < 75 years at time of informed consent
•3. Glycated hemoglobin (HbA1c) >= 6.5 % and < 11.0% at visit 1
•4. Geometric mean of 2 first morning voided urinary albumin-to-creatinine ratio >= 50 to < 300 mg/gCr at visit 2 and visit 3
•5. Estimated glomerular filtration rate (eGFR) >= 45 mL/min per 1.73m2 at visit 1
•6. All subjects are required to have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and are willing to participate in the study

•1. Use of SGLT2 inhibitor <= 12 weeks prior to informed consent
•2. Known allergies or hypersensitivity to canagliflozin or other SGLT2 inhibitors
•3. History of severe diabetic ketosis (including ketoacidosis), diabetic coma or pre-coma
•4. Severe infection, pre- or post-surgery (ie, requiring general anesthesia) or severe trauma at visit1 or visit 3
•5. Urinary tract infection or genital infection at visit1 or visit 3
•6. Underlying renal disease other than diabetic nephropathy at visit1 or visit 3
•7. New York Heart Association Class IV cardiac disease at visit1 or visit 3
•8. Severe hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg) at visit1 or visit 3
•9. History of arteriosclerosis obliterans and/or foot ulcer and/or limb amputation
•10. Pregnant, possibly pregnant, breast-feeding or planning to become pregnant during the study
•11. Medical history of cancer and/or treatment for cancer within the last 5 years at visit1 or visit 3
•12. Severe liver disease at visit1 or visit 3
•13. Treatment with systemic steroids at visit1 or visit 3
•14. Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) at visit1 or visit 3
•15. Reduction in eGFR >= 30% from visit 1 to visit 3
•16. Any condition that, in the opinion of the investigator, would compromise the subject's well-being or ability to perform the study requirements

发起方

Miyamoto Satoshi