UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040442 |
|---|---|
| Receipt number | R000046151 |
| Scientific Title | Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease |
| Date of disclosure of the study information | 2020/05/19 |
| Last modified on | 2020/05/18 21:19:43 |
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Basic information
Public title
Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Acronym
Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Scientific Title
Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Scientific Title:Acronym
Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Region
| Japan |
Condition
Condition
The patients with type 2 diabetes and cardiovascular disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of luseogliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), on left ventricular (LV) diastolic function in patients with type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the septal E/e' ratio as a parameter of LV diastolic function between before and after the start of the luseogliflozin treatment
Key secondary outcomes
The change in various parameters in echocardiogram between before and after the start of the luseogliflozin treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 2.5mg luseogliflozin once a day for 24 weeks
Interventions/Control_2
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
1. Provide written informed concent
2. Aged >=30, <75 at consent
3. Type 2 diabetes mellitus
4. Grycated hemoglobin (HbA1c) (NGSP) of >= 6.5%, < 10.0%
5. previous history of any cardiovascular diseases
6. No experience of SGLT2 inhibitors
Key exclusion criteria
already taking an SGLT2 inhibitor,
age < 30 years or >= 75 years,
diagnosis of type 1 diabetes or insulin-dependent diabetes,
symptomatic heart failure (NYHA II-IV),
severe renal dysfunction (eGFR < 45 mL/min/1.73 m2),
severe liver dysfunction (over 3* upper limit of normal),
diabetic ketoacidosis or diabetic coma
the presence of malignancy.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yujiro |
| Middle name | |
| Last name | Ina |
Organization
Saiseikai Fukuoka General Hospital
Division name
Department of Diabetes
Zip code
810-0001
Address
Tenjin 1-3-46, Fukuoka, Chuo-ku, Fukuoka, Japan
TEL
092-771-8151
yujiroiiii@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Ina |
Organization
Saiseikai Fukuoka General Hospital
Division name
Department of Diabetes
Zip code
810-0001
Address
Tenjin 1-3-46, Fukuoka, Chuo-ku, Fukuoka, Japan
TEL
0927718151
Homepage URL
yujiroiiii@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Fukuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Saiseikai Fukuoka General Hospital
Address
Tenjin 1-3-46, Fukuoka, Chuo-ku, Fukuoka, Japan
Tel
0927718151
yujiroiiii@yahoo.co.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
| 2020 | Year | 05 | Month | 19 | 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
25
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046151
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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