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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021669
Receipt No. R000024857
Scientific Title The impact of the SGLT2 inhibitor on cardiovascular risk factors in patients with type 2 diabetes, an explanatory randomized trial
Date of disclosure of the study information 2016/04/01
Last modified on 2016/04/12

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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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