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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03217409

Enrollment

Registered

2017-07-14

Start date

2017-08-10

Completion date

2019-05-23

Last updated

2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus and Hypercholesterolemia

Brief summary

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

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.

Interventions

DRUGRosuvastatin+Ezetimibe

Rosuvastatin 5mg+Ezetimibe 10mg

DRUGRosuvastatin

Rosuvastatin 5Mg Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Low density lipoprotein cholesterol (LDL-C) (100mg/dL)	baseline, Week 8	The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline
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)	baseline, Week 8	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
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)	baseline, Week 8	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
Thiobarbituric acid reactive substances(TBARs)	baseline, Week 8	Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.
Fibroblast Growth Factor 21	baseline, Week 8	Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026