Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study, we will assess the change of extended renin-angiotensin system including serum ACE-2 and angiotensin(1-7) levels and subclinical atherosclerosis after using fimasartan (an ARB), compared to amlodipine in hypertensive patients with T2DM.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital

Criteria

Inclusion Criteria:

• ≥ 30 years old

• Type 2 diabetes by American Diabetes Association criteria

• HbA1c: 6.5% ≤ - < 10.0%

• Systolic blood pressure: 140 ≤ - < 180 mmHg or Diastolic blood pressure: 85 ≤ - < 110 mmHg

• Statin (-) or no change in low to moderate intensity statin [14] dose in recent 3 months

Exclusion Criteria:

• Contraindication of fimasartan or amlodipine

• History of RAS inhibitors (ACE inhibitors or ARBs) or calcium channel blockers in the previous 3 months

• Pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women

• Type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy

• Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening

• Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)

• Chronic kidney disease (serum creatinine > 2.0 mg/dL)

• Hyperkalemia serum potassium >5.0 mEq/L

• Any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ