UMIN-CTR Clinical Trial

Basic information
Public title	Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Acronym	Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Scientific Title	Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Scientific Title:Acronym	Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare a SGLT2 inhibitor Empagliflozin and other anti diabetic agents on lipid parameter and lipid metabolism in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sterol 3 fractions
Key secondary outcomes	sterol fractionate Triglyceride DUAL-scan

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	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empagliflozin group
Interventions/Control_2	control group
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment. 2)Over 20 years old and less than 80 years old 3)Sex unquestioned 4)Patients with no history of cardiovascular disease 5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization. 6)The patient who gives a written informed
Key exclusion criteria	1)Type 1 diabetes 2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 3)A pregnant woman and/or a woman under breast-feeding 4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women) 5)Diabetic proliferative retinopathy 6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug 7)No treatment with Ezetimibe 8)Patient with intolerance of medical reasons by doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Teruo Middle name Last name Teruo Joijma
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
Zip code	321-0293
Address	880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL	0282-87-2150
Email	jojima@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Teruo Middle name Last name Teruo Joijma
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
Zip code	321-0293
Address	880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL	0282-87-2150
Homepage URL
Email	jojima@dokkyomed.ac.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Dokkyo Medical University
Address	880kita-kobayashi,Mibu,Tochigi,Japan
Tel	0282-87-2275
Email	r-kenkyu@dokkyomed.ac.jp

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	2016 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 26 Day
Last modified on	2020 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029259