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

Primary Purpose

Diabetes Mellitus and Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin+Ezetimibe
Rosuvastatin
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus and Hypercholesterolemia

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Soon Chun Hyang University Hospital Cheonan
  • Soon Chun Hyang University Hospital Gumi
  • Soon Chun Hyang University Hospital Bucheon
  • Soon Chun Hyang University Hospital Seoul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosuvastatin+Ezetimibe

Rosuvastatin

Arm Description

Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week

Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Thiobarbituric acid reactive substances(TBARs)
Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.
Fibroblast Growth Factor 21
Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.

Full Information

First Posted
July 12, 2017
Last Updated
September 19, 2019
Sponsor
Yuhan Corporation
Collaborators
Linical Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03217409
Brief Title
A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
Collaborators
Linical Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus and Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin+Ezetimibe
Arm Type
Experimental
Arm Description
Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin+Ezetimibe
Other Intervention Name(s)
Rosuvamibe ® 10/5mg
Intervention Description
Rosuvastatin 5mg+Ezetimibe 10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Monorova ® 5mg
Intervention Description
Rosuvastatin 5Mg Tablet
Primary Outcome Measure Information:
Title
Low density lipoprotein cholesterol (LDL-C) (%)
Description
The rate of change(%) of LDL-C at Week 8 compared to the baseline
Time Frame
baseline, Week 8
Secondary Outcome Measure Information:
Title
Low density lipoprotein cholesterol (LDL-C) (100mg/dL)
Description
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
Title
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)
Description
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
Title
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)
Description
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
Title
Thiobarbituric acid reactive substances(TBARs)
Description
Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.
Time Frame
baseline, Week 8
Title
Fibroblast Growth Factor 21
Description
Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.
Time Frame
baseline, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Gumi
City
Gumi
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Seoul
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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