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

NCT03446261 | Completed Phase 4

• 1 other identifier: YMC029
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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

Conditions

Type 2 Diabetes Mellitus; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 8 in ApoB/ApoA1 ratio

  Baseline, Week 8

Secondary Outcomes (7)

• Proportion of over 50% reduction in LDL-C

  Baseline, Week 8

• 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

• Change from baseline to week 8 in hs-CRP

  Baseline, Week 8

Study Arms (2)

Rosuvamibe® Tab

EXPERIMENTAL

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

Drug: Rosuvamibe® Tab

Monorova® Tab

ACTIVE COMPARATOR

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

Drug: Monorova® Tab

Interventions

Rosuvamibe® Tab DRUG

Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks

Rosuvamibe® Tab

Monorova® Tab DRUG

Rosuvastatin 10mg qd for 8 weeks

Monorova® Tab

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (2)

Asan Medical Center

Kora-ri, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32065359 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypercholesterolemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: February 23, 2018
• Primary Completion: March 5, 2019
• Study Completion: March 5, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

KR (2)