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
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006918
- Lead Sponsor
- Daiichi-Sankyo Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3000
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Attainment rate of target BP goals* at month 6 after Sevikar HCT® tablet treatment. *Target BP is determined according to the criteria of The Korean society of hypertension (2018). In DM patients, the target BP is decided whether the patients have CVD (defined as coronary artery disease, peripheral vascular disease, aortic disease, heart failure, left ventricular hypertrophy in patients aged 50 years or more) or not. In the absence of CVD, target BP is SBP/DBP<140/85 mmHg whereas the target BP is SBP/DBP<130/80 mmHg in the presence of CVD. For pre-DM or elderly patients, the target BP is SBP/DBP<140/90 mmHg.
- Secondary Outcome Measures
Name Time Method