A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus and Hypercholesterolemia
• Intervention / Treatment: Drug: Rosuvastatin+Ezetimibe; Drug: Rosuvastatin

Detailed Description

This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Gumi, Korea, Republic of
    • Soon Chun Hyang University Hospital Gumi
  • Gyeonggi-do, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Seoul, Korea, Republic of
    • Soon Chun Hyang University Hospital Seoul

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:

• Subjects ≥ 19 or ≤ 75 years of age
• Subjects undergoing treatment for type 2 diabetes
• Subjects undergoing treatment of statin for hypercholesterolemia
• Fasting LDL-C ≤ 250mg/dL at the screening visit
• Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
• Fasting TG<500mg/dL

Exclusion Criteria:

• Subjects with hypersensitivity reaction to Statin and Ezetimibe
• Subjects with severe kidney disease
• Subjects with HIV positive result at the screening
• Pregnant or breast-feeding subjects
• Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
• Insulin-treated Subjects
• Other exclusions applied

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin+Ezetimibe; Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week	Drug: Rosuvastatin+Ezetimibe; Rosuvastatin 5mg+Ezetimibe 10mg; Other Names: Rosuvamibe ® 10/5mg
Active Comparator: Rosuvastatin; Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week	Drug: Rosuvastatin; Rosuvastatin 5Mg Tablet; Other Names: Monorova ® 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low density lipoprotein cholesterol (LDL-C) (%)	The rate of change(%) of LDL-C at Week 8 compared to the baseline	baseline, Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low density lipoprotein cholesterol (LDL-C) (100mg/dL)	The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline	baseline, Week 8
HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß)	Variation of HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) at Week 8 compared to the baseline resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) change form the baseline at Week 8	baseline, Week 8
LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C)	Variation of LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) at Week 8 compared to the baseline Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) change form the base line at Week 8	baseline, Week 8
Thiobarbituric acid reactive substances(TBARs)	Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.	baseline, Week 8
Fibroblast Growth Factor 21	Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.	baseline, Week 8

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Collaborators: Linical Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): May 23, 2019

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Diabetes Mellitus; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Ezetimibe
• Other Study ID Numbers: YMC022

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