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NCT Number: NCT03217409

A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.

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Key information

Conditions

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

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soon Chun Hyang University Hospital Cheonan, Cheonan, South Korea

Loading trial locations.

About this study

This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects ≥ 19 or ≤ 75 years of age
  • Subjects undergoing treatment for type 2 diabetes
  • Subjects undergoing treatment of statin for hypercholesterolemia
  • Fasting LDL-C ≤ 250mg/dL at the screening visit
  • Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
  • Fasting TG<500mg/dL

Exclusion criteria

  • Subjects with hypersensitivity reaction to Statin and Ezetimibe
  • Subjects with severe kidney disease
  • Subjects with HIV positive result at the screening
  • Pregnant or breast-feeding subjects
  • Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
  • Insulin-treated Subjects
  • Other exclusions applied

Treatment and study plan

Rosuvastatin+Ezetimibe

Drug

Rosuvastatin 5mg+Ezetimibe 10mg

Other names: Rosuvamibe ® 10/5mg

Rosuvastatin

Drug

Rosuvastatin 5Mg Tablet

Other names: Monorova ® 5mg

Primary outcomes

  1. Low density lipoprotein cholesterol (LDL-C) (%)

    Time frame: baseline, Week 8

    The rate of change(%) of LDL-C at Week 8 compared to the baseline

Secondary outcomes

  1. Low density lipoprotein cholesterol (LDL-C) (100mg/dL)

    Time frame: baseline, Week 8

    The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline

  2. HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß)

    Time frame: baseline, Week 8

    Variation of HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) at Week 8 compared to the baseline resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) change form the baseline at Week 8

  3. LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C)

    Time frame: baseline, Week 8

    Variation of LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) at Week 8 compared to the baseline Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) change form the base line at Week 8

  4. Thiobarbituric acid reactive substances(TBARs)

    Time frame: baseline, Week 8

    Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.

  5. Fibroblast Growth Factor 21

    Time frame: baseline, Week 8

    Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Collaborators

  • Linical Korea

Registry information

Official study title

A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2017
Registry last updated
Sep 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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