UMIN-CTR Clinical Trial

Basic information
Public title	The impact of the SGLT2 inhibitor on cardiovascular risk factors in patients with type 2 diabetes, an explanatory randomized trial
Acronym	The impact of the SGLT2 inhibitor on cardiovascular risk factors
Scientific Title	The impact of the SGLT2 inhibitor on cardiovascular risk factors in patients with type 2 diabetes, an explanatory randomized trial
Scientific Title:Acronym	The impact of the SGLT2 inhibitor on cardiovascular risk factors
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Gastroenterology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of a SGLT2 inhibitor, Empagliflozin, on myocardial lipid content in patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intramyocardial lipid deposition measured by magnetic resonance spectroscopy (MRS): Time Frame of 8 weeks
Key secondary outcomes

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	8 weeks administration of Empagliflozin 10mg q.d.
Interventions/Control_2	Standard care
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	30 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	HbA1c >= 7.0% and HbA1c < 10%
Key exclusion criteria	1. Diagnosed as diabetes within the last 6 months 2. Taking SGLT2 inhibitors 3. Taking diuretics 4. Pituitary dysfunction or adrenal insufficiency 5. Excessive alcohol intake 8. eGFR < 30mL / min / 1.73m2(MDRD) 9. AST >= 165 or ALT >= 210 10. Serum C-peptide < 0.5ng / mL 11. History of severe hypoglycemia within the last 3 months 12. Systolic blood pressure >= 200 mmHg or diastolic blood pressure >=120 mmHg 13. Secondary hypertension 14. Vitreous hemorrhage, unstable proliferative diabetic retinopathy 15. Severe diabetic neuropathy 16. Positive anti-GAD antibody 17. During pregnancy 18. Chronic atrial fibrillation 19. History of pyelonephritis 20. Claustrophobia, pacemaker, the metal in the body, weighing 150 kg or more 21. Unable to hold the breath longer than 20 seconds
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masato Odawara
Organization	Tokyo Medical University
Division name	Division of Diabetes, Endocrinology and Metabolism
Zip code
Address	6-7-1 Nishishinjyuku, Shinjukuku, Tokyo, Japan
TEL	03-3342-6111
Email	odawara@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuo Hara
Organization	Tokyo Medical University
Division name	Division of Diabetes, Endocrinology and Metabolism
Zip code
Address	6-7-1 Nishishinjyuku, Shinjukuku, Tokyo, Japan
TEL	03-3342-6111
Homepage URL
Email	hara@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Tokyo Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 01 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	Preinitiation
Date of protocol fixation	2015 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 07 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 03 Month 29 Day
Last modified on	2016 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024857

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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