Hypercholesterolemia, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGRosuvamibe® Tab
Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
DRUGMonorova® Tab
Rosuvastatin 10mg qd for 8 weeks
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 8 in ApoB/ApoA1 ratio | Baseline, Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| 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 total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48 | Baseline, Week 8 |
| Change from baseline to week 8 in HOMA-IR | Baseline, Week 8 |
| Proportion of over 50% reduction in LDL-C | Baseline, Week 8 |
| Change from baseline to week 8 in HbA1C | Baseline, Week 8 |
| Change from baseline to week 8 in FPG | Baseline, Week 8 |
| Change from baseline to week 8 in hs-CRP | Baseline, Week 8 |
Countries
South Korea
Outcome results
None listed