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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040442
Receipt No. 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

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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
Email 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
Email yujiroiiii@yahoo.co.jp

Sponsor
Institute Saiseikai Fukuoka General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046151

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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