High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension

Effect of High-Dose Rosuvastatin Combined With Telmisartan or Amlodipine on Glucose Metabolism in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Impaired Fasting Glucose (IFG) and Hypertension: A Randomized, Open-Label, Parallel, Prospective Study

This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.

Study Overview

• Status: Completed
• Conditions: Hypertension; Impaired Fasting Glucose; ASCVD
• Intervention / Treatment: Drug: Duowell®; Drug: Monorova® + Amlopin®

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Dankook University Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • CHA Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent
2. Aged 19 to 75 years

3. Patients with ASCVD requiring high-intensity statin therapy (in accordance with the clinical ASCVD diagnostic criteria in the 2013 ACC/AHA Guideline)

   - Coronary artery disease

   • acute coronary syndrome
   • history of myocardial infarction (MI)
   • stable or unstable angina
   • history of coronary revascularization
   • stroke or transient ischemic attack (TIA)
   • peripheral arterial disease, history of peripheral arterial revascularization
4. Those who are taking antihypertensive drugs, or SBP > 140mmHg or DBP > 90mmHg on the left side

5. High-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria:

   • impaired fasting glucose (IFG): 100-125 mg/dL (5.6-6.9 mmol/L)
   • impaired glucose tolerance (IGT): plasma blood glucose 140-199mg/dL (7.8 to 11.0 mmol/L) 2 hours after oral administration of glucose 75g
   • HbA1c: 5.7-6.4%

Exclusion Criteria:

1. Those who are treated with secondary hypertension or malignant hypertension
2. Uncontrollable diabetes with HbA1c ≥ 10%
3. Total cholesterol ≥ 300mg/dL
4. Fasting LDL-C ≤ 70 mg/dL
5. Fasting triglyceride ≥ 500 mg/dL
6. History of muscular disease or rhabdomyolysis due to use of statin
7. Hypersensitive to statin or ARBs

8. Contraindications stated in the SPC of telmisartan or rosuvastatin including the following:

   • severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
   • ALT, AST > 3x ULN or history of active liver disease
   • CPK > 3x ULN
   • hyperkalemia with serum K > 5.5 mEq/l
9. Those who are participating in clinical trials of other investigational products
10. Those who cannot discontinue all other treatment for hypertension or hyperlipidemia than the investigational products, and concomitant medications and supplements that can affect the therapeutic effect of hypertension and hyperlipidemia during the trial period
11. Other than the above who is deemed to be ineligible to participate in the trial by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Duowell Tab; Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks	Drug: Duowell®; Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
ACTIVE_COMPARATOR: Monorova Tab + Amlopin Tab; Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks	Drug: Monorova® + Amlopin®; Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in HOMA-IR	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in insulin level	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostatic model assessment for β-cell function (HOMA-B)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in C-reactive protein (CRP)	Baseline, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2018
• Primary Completion (ACTUAL): June 7, 2019
• Study Completion (ACTUAL): June 7, 2019

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (ACTUAL): March 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: YMC032

Drug and device information, study documents

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