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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446261
• Other study ID #: YMC029
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2018
• Est. completion date: March 5, 2019

Study information

• Verified date: July 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 5, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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:

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

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

? 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Rosuvamibe® Tab
Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
• Monorova® Tab
Rosuvastatin 10mg qd for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Kora-ri
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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