Clinical trial NCT03217409: A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus and Hypercholesterolemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
Collaborators: name: Linical Korea
First posted: 2017-07-14
Enrollment: 85
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C) (%)
timeFrame: baseline, Week 8
Secondary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C) (100mg/dL)
timeFrame: baseline, Week 8
measure: 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)
timeFrame: baseline, Week 8
measure: 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)
timeFrame: baseline, Week 8
measure: Thiobarbituric acid reactive substances(TBARs)
timeFrame: baseline, Week 8
measure: Fibroblast Growth Factor 21
timeFrame: baseline, Week 8
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Gumi
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Gumi
city: Gyeonggi-do
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
Study officials:
References: