UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for Efficacy of Rosuvastatin on Carotid Intima Media Thickness and Characteristics of Atherosclerosis in Hyperlipidemic Patients with Type 2 Diabetes
Title of the study (Brief title)	Evaluation for Efficacy of Rosuvastatin on Carotid Intima Media Thickness and Characteristics of Atherosclerosis in Hyperlipidemic Patients with Type 2 Diabetes
Region	Japan

Condition
Condition	hyperlipidemic patients with type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the impact of aggressive lipid control with Rosuvastatin administration on features of carotid intima-media thickness (IMT) and arteriosclerosis of hyperlipidemic patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	changes in low-density lipoprotein (LDL) levels after 52 weeks of treatment were analyzed
Key secondary outcomes	mean-IMT, maximal IMT (max-IMT), and max-IMT of the common carotid artery (CCA max-IMT), and ABI (ankle-branchial index), and CAVI(cardio ankle vascular index) after 52 weeks of treatment were analyzed

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rosuvastatin drug was administered at a dose of 5 mg for 52 weeks to hyperlipidemic patients with type 2 diabetes with max-IMT over 1.1 mm despite prior oral administration of a low-intensity statin for at least 3 months.
Interventions/Control_2
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	hyperlipidemic patients with type 2 diabetes who had been treated with a low oral dose of a strong or a mild statin (Pitavastatin 1mg, Atorvastatin 5mg, Pravastatin, Simvastatin, Fluvastatin) for 3 months or more were enrolled (with max-IMT over 1.1 mm )
Key exclusion criteria	(1)Receiving fibrates (2)Hemodialysis (3)Familial hypercholesterolemia (4)Onset a cerebrovascular accident during the preceding period of less than 3 months (5)Severe liver dysfunction (AST over 100IU/L, ALT over 100IU/L, Total bilirubin over 2.5mg/dl) (6)Severe renal dysfunction (serum creatinine over 2.0mg/dl, Ccr 30mL/min (7)Creatine Kinase over 500IU/L (8)Receiving cyclosporine (9)Pregnant or possibly pregnant (10)Hypothyroidism or hereditary myopathy, a family history of these diseases, and a past history of drug-induced myopathy (11)Drug abuse or alcoholism (12)Malignancy (13)Serious complications
Target sample size	30

Research contact person
Name of lead principal investigator	TAKANORI KUDO
Organization	Hachinohe City Hospital
Division name	Department of Endocrinology and Diabetes
Address	Tamukai aza bisyamontaira 1, hachinohe, Aomori
TEL	0178-72-5111
Email	t-ku-do@pb3.so-net.ne.jp

Public contact
Name of contact person	TAKANORI KUDO
Organization	Hachinohe City Hospital
Division name	Department of Endocrinology and Diabetes
Address	Tamukai aza bisyamontaira 1, hachinohe, Aomori
TEL	0178-72-5111
Homepage URL
Email	t-ku-do@pb3.so-net.ne.jp

Sponsor
Institute	Hachinohe City Hospital Department of Endocrinology and Diabetes
Institute
Department

Funding Source
Organization	Hachinohe City Hospital Department of Endocrinology and Diabetes
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 04 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date
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	2015 Year 04 Month 20 Day
Last modified on	2018 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019956