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

Nippon Medical School- Tohoku University Graduate School Intervention with Pitavastatin: Study for hypercholesterolemia with type 2 diabetes mellitus. - Nippon medical school, Tohoku university, Plaque Prevention study (NTPP study)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000328
Enrollment
100
Registered
2006-03-01
Start date
2006-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemic patients with type 2 diabetes mellitus

Interventions

Pitavastatin 1 mg or 2 mg daily for a period of 36 months Pravastatin 10 mg daily for a period of 36 months

Sponsors

Dyslipidemia with diabetes study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who (1)are treated with diet, exercise and/or medication for at least 8 weeks, with HbA1c /= 140 mg/dL (by the Friedewald formula) at measurements in the run-in period. (3)have fasting serum levels of triglyceride < 400 mg/dL. (4)are diagnosed with type 2 diabetes. (5)are at age of 20 to 75 years at time of consent. (6)male or female (7)provide written informed concent for participation in the study voluntarily after being fully informed and explained.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
A change of intima-media thickness (IMT)of common carotid artery—

Secondary

MeasureTime frame
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—

Countries

Japan

Contacts

Public ContactYasushi Ishigaki

Dyslipidemia with diabetes study group Molecular Metabolism and Diabetes, Tohoku University, Graduate School of Medicine

yishigaki@int3.tohoku.ac.jp022-717-7611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026