KCT0006918
Recruiting
未知
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 sites3,000 target enrollmentTBD
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Daiichi-Sankyo Korea
- Enrollment
- 3000
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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%
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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