Diabetes Mellitus and Hypercholesterolemia Clinical Trial
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
| NCT number | NCT03217409 |
| Other study ID # | YMC022 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | August 10, 2017 |
| Est. completion date | May 23, 2019 |
| Verified date | September 2019 |
| Source | Yuhan Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | May 23, 2019 |
| Est. primary completion date | April 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Soon Chun Hyang University Hospital Cheonan | Cheonan | |
| Korea, Republic of | Soon Chun Hyang University Hospital Gumi | Gumi | |
| Korea, Republic of | Soon Chun Hyang University Hospital Bucheon | Gyeonggi-do | |
| Korea, Republic of | Soon Chun Hyang University Hospital Seoul | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yuhan Corporation | Linical Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Low density lipoprotein cholesterol (LDL-C) (%) | The rate of change(%) of LDL-C at Week 8 compared to the baseline | baseline, Week 8 | |
| Secondary | Low density lipoprotein cholesterol (LDL-C) (100mg/dL) | The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline | baseline, Week 8 | |
| Secondary | 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) | 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 | baseline, Week 8 | |
| Secondary | 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) | 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 | baseline, Week 8 | |
| Secondary | Thiobarbituric acid reactive substances(TBARs) | Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline. | baseline, Week 8 | |
| Secondary | Fibroblast Growth Factor 21 | Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline. | baseline, Week 8 |