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

Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Diabetes Mellitus, Type 2; Atherosclerosis; Renin Hypertension
• Intervention / Treatment: Drug: Fimasartan

Detailed Description

Several clinical trials aimed at studying the benefits of RAS blockade in the diabetic complications. HOPE, RENAAL, IRMA2, IDNT, ONTARGET studies proved that ACE inhibitors or ARBs reduced the risk of diabetic complications.

Recent studies proved that fimasartan, one of the ARBs, stabilizes the activity of renin-angiotensin system. However, understanding the change in concentration of serum ACE, ACE-2, angiotensin(1-7), and angiotensin-II should help clinicians select more appropriate drug between ACE inhibitors and ARBs with clear evidence. Moreover, since RAS antagonists are the first-line drugs for antihypertensive therapy in patients with T2DM, it is meaningful to understand the change of RAS-related factors in serum after using the drugs.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Soo Lim, MD, PHD; Phone Number: 01097662706; Email: limsoo@snu.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Soo Lim, MD, PHD; Phone Number: 82-31-787-7035; Email: limsoo@snu.ac.kr
      • Principal Investigator: Soo Lim, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fimasartan; - Fimasartan group: Fimasartan, 60 mg once a day, oral administration	Drug: Fimasartan; - Fimasartan group: fimasartan, 60 mg once a day, oral administration; Other Names: Kanarb
Active Comparator: Amlodipine; - Comparator group: Amlodipine, 5 mg once a day, oral administration	Drug: Fimasartan; - Fimasartan group: fimasartan, 60 mg once a day, oral administration; Other Names: Kanarb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiotensin(1-7)	Changes of serum angiotensin(1-7) at week 12 from baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Change in blood pressure from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
ACE-2	Change in ACE-2 from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
ACE	Change in ACE from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
Renin	Change in renin from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
angiotensin	Change in angiotensin from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
atherosclerosis	Change in atherosclerosis from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
Muscle mass	Change in muscle mass from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
Fat mass	Change in fat mass from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks
HbA1c	Change in HbA1c from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24	12 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Atherosclerosis
• Other Study ID Numbers: B-1606-351-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No