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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypercholesterolemia
• Interventions: Drug: Rosuvamibe® Tab; Drug: Monorova® Tab

• Registration Number: NCT03446261
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Study Start: 2018-02-23
• Study First Posted: 2018-02-26
• Primary Completion: 2019-03-05
• Study Completion: 2019-03-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-21
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvamibe® Tab	Rosuvamibe® Tab	Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks
Monorova® Tab	Monorova® Tab	Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 8 in ApoB/ApoA1 ratio	Baseline, Week 8

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of