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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2019-03-05

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvamibe® Tab

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

Group Type EXPERIMENTAL

Rosuvamibe® Tab

Intervention Type DRUG

Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks

Monorova® Tab

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

Group Type ACTIVE_COMPARATOR

Monorova® Tab

Intervention Type DRUG

Rosuvastatin 10mg qd for 8 weeks

Interventions

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Rosuvamibe® Tab

Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks

Intervention Type DRUG

Monorova® Tab

Rosuvastatin 10mg qd for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No