Hypercholesterolemiac patients with diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Hypercholesterolemic patients with diabetes mellitus with diabetes mellitus (1) Patients who has administered sitagliptin for more than 12 weeks (2) Patients whose HbA1c is stable between 5.8% and 8.0% during 12-week sitagliptin therapy (3) Patients whose LDL-C is between 120 mg/dL and 160 mg/dL (4) Patients who voluntarily provide informed consent with sufficient comprehension after receiving sufficient explanation of this study
Exclusion criteria
Exclusion criteria: (1) Patients under insulin treatment (2) Patients with history of cardiovascular events (ischemic heart disease, cerebral vascular disease, etc.) (3) CK (CPK) > upper limit of normal (ULN) (4) AST (GOT) and ALT (GPT) > 3 times ULN (5) Serum creatinine > 1.5 mg/dL for male, 1.3 mg/dL for female, eGFR < 50 ml/min/1.73 m2 (6) Patients judged to be inappropriate for this study by the investigators (7) Under 20 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of HbA1c from the baseline to 24 weeks | — |
Countries
Japan