UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effects by strong statins on the lipoprotein components and the renal function in patients with diabetes. - Study in the cases switched from Atorvastatin to Rosuvastatin-
Title of the study (Brief title)	Effects of Rosuvastatin on the lipoprotein components and the renal function in patients with diabetes.
Region	Japan

Condition
Condition	Diabetes patients with dyslipidemia
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to elucidate whether the profiles of lipoprotein components such as IDL and s-LDL are improved by switching from Atorvastatin to Rosuvastation which has stronger potency of LDL-C lowering.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.The changes in s-LDL,IDL,LDL and HDL after switching. 2.Renoprotective effects of each statin(SCr,eGFR,Cystatin-C,Urinary albumin),HbA1c,CK,muscle spasms of the lower extremities.
Key secondary outcomes	1.The achievement ratio according to the management target level of LDL-C in JASGL2012 2.Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	5mg Rosuvastatin will be orally administered once daily for 12 months.
Interventions/Control_2	10mg Atorvastatin will be orally administered once daily for 12 months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with diabetes 2) Patients who have been taking 10mg atorvastatin for more than 3 months 3) Patients whose HDL-C levels are less than 50mg/dL 4) Patiens who were recognized the existence of either s-LDL or IDL by Lipofo-AS kit. 5) Patients whose serum Cr levels less than or equql to 2.5mg/dL 6) Patients whose HbA1c levels(NGSP) are less than 10.4%.
Key exclusion criteria	1) Patients whose electrocardiograms at rest obviously showed the finding of myocardial ischemia. 2) Patients whose serum triglyceride levels are more than 400 mg/dL. 3) Patients whose HbA1c levels varied more than 2% within 3 months. 4) Patients who were judged as ineligible by investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	Yukihiro Bando
Organization	Saiseikai Fukui Hospital
Division name	internal medicine
Address	7-1 Funahashi Wadanaka-cho,Fukui-city,Fukui
TEL	0776-23-1111
Email	bando.yukihiro5002@fukui.saiseikai.or.jp

Public contact
Name of contact person	Yukihiro Bando
Organization	Saiseikai Fukui Hospital
Division name	internal medicine
Address	7-1 Funahashi Wadanaka-cho,Fukui-city,Fukui
TEL	0776-23-1111
Homepage URL
Email	y-bando@fukui.saiseikai.or.jp

Sponsor
Institute	Fukui Saiseiki Hospital
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 24 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date	2013 Year 05 Month 31 Day
Date of closure to data entry	2013 Year 08 Month 30 Day
Date trial data considered complete	2013 Year 10 Month 15 Day
Date analysis concluded	2013 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 23 Day
Last modified on	2018 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010743