UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparative clinical trial on the effects of atorvastatin 10mg and atorvastatin 5mg/ ezetimibe 10mg in type 2 diabetic patients with nephropathy and hypercholesterolemia
Title of the study (Brief title)	Comparison of the effects of atorvastatin high dose and atorvastatin/ezetimibe combination therapy
Region	Japan

Condition
Condition	Type 2 diabetic patients with nephropathy and hypercholesterolemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the effects of atorvastatin 10mg and atorvastatin 5mg/ezetimibe10mg on lipid profile, renal function and safety in type 2 diabetic patients with nephropathy and hypercholesterolemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in non-HDL cholesterol at 12 weeks after administration
Key secondary outcomes	Change in lipid profile (TC, LDL-C, HDL-C, TG, RLP), parameters related to renal function (urine albuminm, urine collagen IV, L-FABP), parameters related to glucose metabolism (fasting glucose, HbA1c), and safety at 12 weeks after administration

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	YES
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Each subject will orally receive atorvastatin 10mg once daily for 3 months.
Interventions/Control_2	Each subject will orally receive atorvastatin 5mg and ezetimibe 10mg once daily for 3 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) During of atorvastatin (5mg once daily) treatment more than 3 months 2) LDL-C>=100mg/dL 3) CKD stage G3a and G3b (30<=eGFR<60) 4) Age>=20 years old 5) No change in medication of lipid-lowering and antidiabetic drug within 12 weeks 6) 6.5%<=HbA1c<=8% (NGSP) 7) Patients with written IC
Key exclusion criteria	1) Patients with hypersensitivity of the test drugs 2) Patients with hepatic dysfunction(AST or ALT>=100U) 3) Patients with a past history of cerebrovascular or cardiovascular event 4) Patients with secondary or drug-induced hyperlipidemia 5) Patients with familial hypercholesterolemia 6) Pregnant or possibly pregnant patients, patients on lactation 7) Patients with insulin treatment 8) Patients with fibrate treatment 9) Inappropriate patients for this study according to the judgment of Investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Nobuichi Kuribayashi
Organization	Misaki Naika Clinic
Division name	Internal medicine
Address	6-44-9, Futawa-higashi, Funabashi city, Chiba
TEL	047-440-2222
Email	n-kuribayashi@am.wakwak.com

Public contact
Name of contact person	Nobuichi Kuribayashi
Organization	Misaki Naika Clinic
Division name	Internal medicine
Address	6-44-9, Futawa-higashi, Funabashi city, Chiba
TEL	047-440-2222
Homepage URL
Email	n-kuribayashi@am.wakwak.com

Sponsor
Institute	Misaki Naika Clinic
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	三咲内科クリニック

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry	2016 Year 01 Month 14 Day
Date trial data considered complete	2016 Year 02 Month 22 Day
Date analysis concluded	2016 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Compared with the atorvastatin group, the rate of reduction of non HDL-C and LDL-C was significantly larger in the ezetimibe group. Renal marker and safety did not differ between the two groups.
Other related information

Management information
Registered date	2017 Year 01 Month 11 Day
Last modified on	2017 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029476