Clinical trial NCT03446261: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Hypercholesterolemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to week 8 in ApoB/ApoA1 ratio
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Proportion of over 50% reduction in LDL-C
timeFrame: Baseline, Week 8
measure: Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)
timeFrame: Baseline, Week 8
measure: Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48
timeFrame: Baseline, Week 8
measure: Change from baseline to week 8 in HOMA-IR
timeFrame: Baseline, Week 8
measure: Change from baseline to week 8 in hs-CRP
timeFrame: Baseline, Week 8
measure: Change from baseline to week 8 in HbA1C
timeFrame: Baseline, Week 8
measure: Change from baseline to week 8 in FPG
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Kora-ri
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
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.