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CompletedNCT03446261Updated Jul 23, 2019

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

A Phase 4 interventional study of Rosuvamibe® Tab and Monorova® Tab in Type 2 Diabetes Mellitus and Hypercholesterolemia, sponsored by Yuhan Corporation. Completed at 2 sites in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-23.

Sponsored by Yuhan Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Hypercholesterolemia
03

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Rosuvamibe® Tab

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

    Drug: Rosuvamibe® Tab

  • Active comparator
    Monorova® Tab

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

    Drug: Monorova® Tab

Interventions

  • DrugRosuvamibe® Tab

    Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks

  • DrugMonorova® Tab

    Rosuvastatin 10mg qd for 8 weeks

05

What researchers measure

Primary outcomes

  1. Change from baseline to week 8 in ApoB/ApoA1 ratio

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Proportion of over 50% reduction in LDL-C

    Time frame: Baseline, Week 8

  2. Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)

    Time frame: Baseline, Week 8

  3. Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48

    Time frame: Baseline, Week 8

  4. Change from baseline to week 8 in HOMA-IR

    Time frame: Baseline, Week 8

  5. Change from baseline to week 8 in hs-CRP

    Time frame: Baseline, Week 8

  6. Change from baseline to week 8 in HbA1C

    Time frame: Baseline, Week 8

  7. Change from baseline to week 8 in FPG

    Time frame: Baseline, Week 8

06

Study locations

2 sites
  • Asan Medical Center
    Kora-ri, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
07

References and documents

Publications

  • 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. PubMed 32065359 ↗
08

Registry details

Key details

Study ID
NCT03446261
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Feb 23, 2018
Primary completion
Mar 5, 2019
Completion
Mar 5, 2019
Last update
Jul 23, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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