Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

July 21, 2019 updated by: Yuhan Corporation

A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy vs Rosuvastatin Monotherapy in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Kora-ri, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 19 to 70 years
  2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia
  3. Written informed consent

Exclusion Criteria:

  1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
  2. Uncontrollable diabetes with HbA1c ≥ 8.5%
  3. Fasting LDL-C ≤ 70 mg/dL
  4. Fasting triglyceride ≥ 400 mg/dL
  5. Total cholesterol ≥ 300 mg/dL
  6. History of muscular disease or rhabdomyolysis due to use of statin
  7. Hypersensitive to rosuvastatin or ezetemibe

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

    ① Severe renal disease (estimated GFR(MDRD) < 30mL/min/1.73m2)

    ② ALT, AST > 3x ULN or history of active liver disease

    ③ CPK > 3x ULN

  9. Administration of other investigational products within 30 days prior to screening visit
  10. Other than the above who is deemed to be ineligible to participate in the trial by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvamibe® Tab
Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks
Drug: Rosuvamibe® Tab
Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
Active Comparator: Monorova® Tab
Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks
Drug: Monorova® Tab
Rosuvastatin 10mg qd for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to week 8 in ApoB/ApoA1 ratio
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of over 50% reduction in LDL-C
Time Frame: Baseline, Week 8
Baseline, Week 8
Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from baseline to week 8 in HOMA-IR
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from baseline to week 8 in hs-CRP
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from baseline to week 8 in HbA1C
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from baseline to week 8 in FPG
Time Frame: Baseline, Week 8
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

March 5, 2019

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 21, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YMC029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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