A prospective, single-arm, multicenter, investigator-initiated, interventional study to evaluate the efficacy and safety of switching from low- and moderate-intensity statin to Ezetimibe 10 mg and ROsuvastatIn 2.5 mg CombinAtion therapy in patients with type 2 diabetes mellitus with dyslipidemia. (EROICA)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008224

Enrollment

665

Registered

2023-02-23

Start date

2023-04-19

Completion date

Unknown

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : This clinical trial is a single-group, multicenter, researcher-led interventional study for patients with type 2 diabetes with dyslipidemia who switched from a single drug of less than modera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults over the age of 19 2. Patients diagnosed with type 2 diabetes 3. Patients with dyslipidemia who have been taking a single drug of less than moderate strength for at least 12 weeks 4. Patients with LDL-C =70 mg/dL and HbA1c <9% before enrollment 5. Patients with diabetes for more than 10 years or with one or more of the major cardiovascular risk factors* (*: age (male =45 years, female =55 years), family history of early cardiovascular disease, high blood pressure, smoking, low HDL cholesterol) 6. Patients who voluntarily gave written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients who fall under the contraindications of the precautions for use of the drug for this study (1) Patients with hypersensitivity to the main ingredient or components of this drug (2) Patients with active liver disease (3) Myopathy patients (4) Patients taking cyclosporine concomitantly (5) Patients with severe renal impairment (creatinine clearance (CrCL) < 30 mL/min) 2. Pregnant or possibly pregnant women and lactating women 3. Patients who were judged inappropriate under the judgment of the researcher because they fall under the cautious administration category of this drug 4. Patients judged unsuitable for participation in this study by other researchers

Design outcomes

Primary

Measure	Time frame
Ratio (%) of subjects whose LDL-C reached less than 70 mg/dL at 12 weeks after switching to Rosuzet Tablet 10/2.5 mg (Baseline)	—

Secondary

Measure	Time frame
Change amount (mg/dL) and rate (%) of lipid profile (TC, LDL-C, HDL-C, non-HDL-C, TG, ApoA1, ApoB);Changes in glucose metabolism and insulin resistance (HbA1c, FPG, HOMA-IR);All adverse events expressed;Severity and course of adverse events and causal relationship with the drug under investigation	—

Countries

Korea, Republic of

Contacts

Public ContactLee Changbum

Hanyang University Guri Hospital

lekang@hanyang.ac.kr+82-31-560-2153

Outcome results