ippon Medical School- Tohoku University Graduate School Intervention with Pitavastatin: Study for hypercholesterolemia with type 2 diabetes mellitus.

Not Applicable

• Conditions: Hypercholesterolemic patients with type 2 diabetes mellitus

• Registration Number: JPRN-C000000328
• Lead Sponsor: Dyslipidemia with diabetes study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-01
• Study Completion: 2009-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Uncontrolled diabetes mellitus (HbA1c >/= 8.0%). (2)Known hypersensitivity or history of clinically significant adverse reactions to any component of drugs. (3)Have serious hypertension (systolic blood pressure >/= 180 mmHg, or diastolic blood pressure >/= 110 mmHg) (4)History of stroke, myocardial infarction (observed within the immediate 3 months prior to screening) or heart failure. (5)Patients with serious renal disfunction or serum creatinine more than 1.5 mg/dL. (6)Patients who are relevant to contraindications listed in statin labellings. * Patients with serious liver dysfunction or biliary obstruction. * Patients who are being treated with cyclosporine. * Pregnant, possibly pregnant, or lactating. * Patients, taking fibrates, with laboratory test abnormalities in renal function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A change of intima-media thickness (IMT)of common carotid artery

Secondary Outcome Measures

Name	Time	Method
A change of the following items (1)Serum lipid profile (LDL-C, triglyceride, HDL-C) (2)Atherosclerosis-related markers (adiponectin, hsCRP, PCOOH, urinary 8-OH-dG) (3)LPL mass (4)Plasma glucose (fasting plasma glucose, HbA1c) (5)Microalbuminuria Evaluation of adverse events and laboratory test abnormalities