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Completed

NCT Number: NCT03446261

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

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

Completed

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Kora-ri, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 19 to 70 years
  • Patient with type 2 diabetes who needs treatment for hypercholesterolemia
  • Written informed consent

Exclusion criteria

  • Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
  • Uncontrollable diabetes with HbA1c ≥ 8.5%
  • Fasting LDL-C ≤ 70 mg/dL
  • Fasting triglyceride ≥ 400 mg/dL
  • Total cholesterol ≥ 300 mg/dL
  • History of muscular disease or rhabdomyolysis due to use of statin
  • Hypersensitive to rosuvastatin or ezetemibe
  • 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

  • Administration of other investigational products within 30 days prior to screening visit
  • Other than the above who is deemed to be ineligible to participate in the trial by investigator

Treatment and study plan

Rosuvamibe® Tab

Drug

Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks

Monorova® Tab

Drug

Rosuvastatin 10mg qd for 8 weeks

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

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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