Type 2 diabetic patients with nephropathy and hypercholesterolemia
Conditions
Interventions
Each subject will orally receive atorvastatin 10mg once daily for 3 months.
Each subject will orally receive atorvastatin 5mg and ezetimibe 10mg once daily for 3 months.
Sponsors
Misaki Naika Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) During of atorvastatin (5mg once daily) treatment more than 3 months 2) LDL-C>=100mg/dL 3) CKD stage G3a and G3b (30<=eGFR<60) 4) Age>=20 years old 5) No change in medication of lipid-lowering and antidiabetic drug within 12 weeks 6) 6.5%<=HbA1c<=8% (NGSP) 7) Patients with written IC
Exclusion criteria
Exclusion criteria: 1) Patients with hypersensitivity of the test drugs 2) Patients with hepatic dysfunction(AST or ALT>=100U) 3) Patients with a past history of cerebrovascular or cardiovascular event 4) Patients with secondary or drug-induced hyperlipidemia 5) Patients with familial hypercholesterolemia 6) Pregnant or possibly pregnant patients, patients on lactation 7) Patients with insulin treatment 8) Patients with fibrate treatment 9) Inappropriate patients for this study according to the judgment of Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in non-HDL cholesterol at 12 weeks after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lipid profile (TC, LDL-C, HDL-C, TG, RLP), parameters related to renal function (urine albuminm, urine collagen IV, L-FABP), parameters related to glucose metabolism (fasting glucose, HbA1c), and safety at 12 weeks after administration | — |
Countries
Japan
Contacts
Public ContactNobuichi Kuribayashi
Misaki Naika Clinic Internal medicine
Outcome results
None listed