UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021669 |
|---|---|
| Receipt number | 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 17:42:06 |
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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
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
hara@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024857
