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

Primary Purpose

Type 2 Diabetes Mellitus, Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvamibe® Tab
Monorova® Tab
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosuvamibe® Tab

Monorova® Tab

Arm Description

Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks

Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks

Outcomes

Primary Outcome Measures

Change from baseline to week 8 in ApoB/ApoA1 ratio

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2018
Last Updated
July 21, 2019
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03446261
Brief Title
Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
March 5, 2019 (Actual)

3. Sponsor/Collaborators

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

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypercholesterolemia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Rosuvamibe® Tab
Arm Type
Experimental
Arm Description
Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks
Arm Title
Monorova® Tab
Arm Type
Active Comparator
Arm Description
Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Rosuvamibe® Tab
Intervention Description
Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Monorova® Tab
Intervention Description
Rosuvastatin 10mg qd for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline to week 8 in ApoB/ApoA1 ratio
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Proportion of over 50% reduction in LDL-C
Time Frame
Baseline, Week 8
Title
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
Title
Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48
Time Frame
Baseline, Week 8
Title
Change from baseline to week 8 in HOMA-IR
Time Frame
Baseline, Week 8
Title
Change from baseline to week 8 in hs-CRP
Time Frame
Baseline, Week 8
Title
Change from baseline to week 8 in HbA1C
Time Frame
Baseline, Week 8
Title
Change from baseline to week 8 in FPG
Time Frame
Baseline, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 19 to 70 years Patient with type 2 diabetes who needs treatment for hypercholesterolemia Written informed consent Exclusion Criteria: Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit Uncontrollable diabetes with HbA1c ≥ 8.5% Fasting LDL-C ≤ 70 mg/dL Fasting triglyceride ≥ 400 mg/dL Total cholesterol ≥ 300 mg/dL History of muscular disease or rhabdomyolysis due to use of statin Hypersensitive to rosuvastatin or ezetemibe 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 Administration of other investigational products within 30 days prior to screening visit Other than the above who is deemed to be ineligible to participate in the trial by investigator
Facility Information:
Facility Name
Asan Medical Center
City
Kora-ri
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32065359
Citation
Lee J, Hwang YC, Lee WJ, Won JC, Song KH, Park CY, Ahn KJ, Park JY. Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study. Diabetes Ther. 2020 Apr;11(4):859-871. doi: 10.1007/s13300-020-00778-1. Epub 2020 Feb 17.
Results Reference
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Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

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