NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002261

Registered date:28/07/2009

Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPateients with type II diabetes combined with dyslipidemia
Date of first enrollment2009/06/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Ezetimibe and Statin

Outcome(s)

Primary OutcomeExamination of the rate change of glucouse metabolism and inflammatory marker Examination of ameliorating effect in kidney function
Secondary OutcomeExamination of the rate change of TC, HDL cholesterol, and TG Decreasing rate of LDL cholesterol

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Pregnant and/or breathfeeding, child-bearing potential women during this study. 2) Past history of severe allergic reactions to ezetimibe 3) Renal dysfunctioned. (ALT>2 x Normal range of each institute) 4) Uncontrolled diabetes mellitus (HbA1c>=9%) 5) Renal insufficiency (serum creatinine>2.0mg/dL) 6) Heart failure, cardiac infarct, unstable angina, or stroke whithin 3 months. 7) Recieving insulin therapy 8) Secondary hyperlipidemia and/or drug-induced hyperlipidemia 9) Familial hyperlipidemia 10) otherwise, treating physician judged not to be appropriate for inclusion in this study.

Related Information

Contact

public contact
Name Koichi Node, MD, PhD
Address 5-1-1 Nabeshima, Saga Japan
Telephone 0952-34-2364
E-mail node@cc.saga-u.ac.jp
Affiliation Saga University Department of Cardiovascular Medicine
scientific contact
Name Koichi Node, MD, PhD
Address 5-1-1, Nabeshima, Saga city, Saga Japan
Telephone 0952-34-2364
E-mail node@cc.saga-u.ac.jp
Affiliation Saga University Department of Cardiovascular Medicine