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

Yuhan Corporation85 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus and Hypercholesterolemia

Interventions

Rosuvastatin+EzetimibeDRUG

Rosuvastatin 5mg+Ezetimibe 10mg

RosuvastatinDRUG

Rosuvastatin 5Mg Tablet

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Soon Chun Hyang University Hospital Gumi

Gumi, South Korea

Soon Chun Hyang University Hospital Bucheon

Gyeonggi-do, South Korea

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Outcomes

Primary Outcomes

Low density lipoprotein cholesterol (LDL-C) (%)

The rate of change(%) of LDL-C at Week 8 compared to the baseline

Time frame: baseline, Week 8

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: baseline, Week 8

Data from ClinicalTrials.gov

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