type 2 diabetes mellitus
Conditions
Interventions
atorvastatin 10mg and ezetimibe 10mg/ atorvastatin 20mg
pitavastatin 1mg and ezetimibe 10mg/ pitavastatin 2mg
Sponsors
Clinical study group for diabetes and dyslipidemia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Type 2 diabetes. (2) Serum LDL-C over 120mg/dL after administration of atorvastatin 10mg or pitavastatin 1mg for one month or more.
Exclusion criteria
Exclusion criteria: (1) History of hypersensitivity to atorvastatin, pitavastatin or ezetimibe (2) Serum triglyceride level more than 400mg/dl (3) Hepatic dysfunction (an alanine aminotransferase level that is more than twice the upper limit of the normal range) (4) Uncontrolled diabetes (HbA1c more than 9.0%) (5) Renal dysfunction (a creatinine level that is higher than 2.0 mg per deciliter) (6) Secondary or drug-induced hypercholesterolemia (7) Homozygous familial hypercholesterolemia (8) Pregnant or nursing women or women suspect of pregnancy (9) Judged as inappropriate for study by doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction in LDL-C from baseline to study endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who reached the treatment goals (LDL-C 120mg/dl or 100mg/dl). Percent change of serum lipids, serum markers of glucose metabolism and serum markers of inflammation. | — |
Countries
Japan
Outcome results
None listed