A prospective, non-interventional, multicenter, observational study to investigate the effectiveness and safety of Sevikar HCT® Tablet in hypertensive patients with type 2 diabetes mellitus or prediabetes in Korea

Daiichi-Sankyo Korea0 个研究点目标入组 3,000 人开始时间: 待定最近更新: 2022年2月7日

适应症

试验速览

暂无简介。

•1. Hypertensive patient with T2DM or pre-DM eligible to receive treatment with Sevikar HCT® tablet at the medical discretion of their treating physician. The diagnostic criteria of T2DM and pre-DM in this study are complied with the criteria of The Korean Diabetes Association (2019) as follows:
•- T2DM (at least one of the following)
•1) HbA1c value is over 6.5% or
•2) Fasting glucose concentration (FGC) is greater than or equal to 126 mg/dL after at least 8 hours of fasting or
•3) Plasma glucose concentration after 2 hours of 75g oral glucose tolerance test (OGTT) is greater than or equal to 200 mg/dL or
•4) Plasma glucose concentration is greater than or equal to 200 mg/dL according to random plasma glucose test with typical symptoms of DM and hyperglycemia (Polyuria, polyphagia, weight loss of unknown cause)
•- Pre-DM (at least one of the following)
•1) Impaired fasting glucose (IFG): fasting plasma glucose concentration is 100~125 mg/dL
•2) Impaired glucose tolerance (IGT): Plasma glucose concentration after 2 hours of OGTT is 140~199 mg/dL
•3) HbA1c value is 5.7~6.4%
•2. Patient or his/her legally authorized representative who agrees and signs a written informed consent on the use of information

•1. Patients who have been prescribed Sevikar HCT® tablet within 3 months of entering the study
•2. Patients determined to be ineligible for participation in this study at the discretion of the treating physician

发起方

Daiichi-Sankyo Korea