UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical study of correlation between cholesterol-lowering therapy and the progression of atherosclerosis in type 2 diabetes mellitus
Title of the study (Brief title)	The clinical study of correlation between cholesterol-lowering therapy and the progression of atherosclerosis in type 2 diabetes mellitus
Region	Japan

Condition
Condition	Atherosclerotic disease in type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Normal therapy group are intervened based on guidline, Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012, with the goal of lowering LDL-C to less than 120 mg/dl. Intensive therapy group, are intervened with the goal of lowering LDL-C to less than 80 mg/dl, with which it is reported that coronary plaque can regression by meta-analysis of clinical trial data. To establish the most effective lipid lowering therapy, this study will investigate the difference of the atherosclerotic progression between intensive therapy group and standard therapy group.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.the progression of intima-media thickness 2.the progression of pulse wave velocity
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Other
Interventions/Control_1	< intensive therapy group > Based on guidline, Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012, with the goal of lowering LDL-C to less than 80 mg/dl.
Interventions/Control_2	< standard therapy group > Based on guidline, JAS Guidelines 2012, with the goal of lowering LDL-C to less than 120 mg/dl.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 Diabetes Mellitus patients whose LDL-C more than 120 mg/dL at the time of the clinical study start
Key exclusion criteria	1.The patients with cerebrovascular disease that developed recently, within 12 weeks. 2.The patients whose fasting triglyceride level>400 mg/dl 3.The patients who have histry of coronary heart disease 4.The patients with liver disfunction 5.The patients with renal disfunction, serum creatinine level is mere than 2 times of the facilities standard. 6.The patients with uncontroled respiratory failure, heart failure and arrhythmia etc. 7.The patients with Familial hypercholesterolemia. 8.The patients with alcoholicsm or medicinal intoxication. 9.The patients who are pregnant, lactating and may be pregnant. 10.The patients who doctors judge as unfitness.
Target sample size	200

Research contact person
Name of lead principal investigator	Takeshi Matsumura
Organization	Kumamoto University Hospital
Division name	Metabolism and Endocrinology
Address	1-1-1 Honjo, Chuo, Kumamoto, 860-8556, Japan
TEL	096-373-5169
Email	takeshim@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person	Takeshi Matsumura
Organization	Kumamoto University Hospital
Division name	Metabolism and Endocrinology
Address	1-1-1 Honjo, Chuo, Kumamoto, 860-8556, Japan
TEL	096-373-5169
Homepage URL
Email	takeshim@gpo.kumamoto-u.ac.jp

Sponsor
Institute	Human Ethics Review Committee of Kumamoto University
Institute
Department

Funding Source
Organization	This work was supported by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Scienc, Japan.
Organization
Division
Category of Funding 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	2014 Year 12 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 10 Month 27 Day
Last follow-up date	2016 Year 04 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 12 Month 12 Day
Last modified on	2016 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018046