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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030128
Receipt No. R000034400
Scientific Title The Japanese Study for Efficacy of Luseogliflozin on composite Endpoint, Compared to DPP-4 inhibitors, in Type 2 diabetes mellitus patients (J-SELECT study)
Date of disclosure of the study information 2017/11/27
Last modified on 2018/03/03

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Basic information
Public title The Japanese Study for Efficacy of Luseogliflozin on composite Endpoint, Compared to DPP-4 inhibitors, in Type 2 diabetes mellitus patients (J-SELECT study)
Acronym The Japanese Study for Efficacy of Luseogliflozin on composite Endpoint, Compared to DPP-4 inhibitors, in Type 2 diabetes mellitus patients (J-SELECT study)
Scientific Title The Japanese Study for Efficacy of Luseogliflozin on composite Endpoint, Compared to DPP-4 inhibitors, in Type 2 diabetes mellitus patients (J-SELECT study)
Scientific Title:Acronym The Japanese Study for Efficacy of Luseogliflozin on composite Endpoint, Compared to DPP-4 inhibitors, in Type 2 diabetes mellitus patients (J-SELECT study)
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of SGLT2 inhibitor (luseogliflozin) on composite endpoint (HbA1c, body weight, blood pressure, pulse, and eGFR), compared to DPP-4 inhibitors, in type 2 diabetes mellitus patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Achievement ratio of patients who improved three or more endpoints among five endpoints listed below from baseline to week 52 (achievement ratio of composite endpoint)
HbA1c (change from baseline < 0)
Body weight (change from baseline < 0)
eGFR (change from baseline > 0)
Blood pressure (change from baseline < 0)
Pulse (change from baseline < 0)
Key secondary outcomes 1. Achievement ratio of the composite endpoint from baseline to week 24
2. Change of HbA1c from baseline
3. Change of body weight from baseline
4. Change of eGFR from baseline
5. Change of blood pressure from baseline
6. Change of pulse from baseline
7. Change of blood test values (or percent change in lipid biomarker values) from baseline
- lipid biomarkers: HDL-chol, T-chol, LDL-chol, TG
- hepatic biomarkers: AST, ALT, gamma-GTP
- others: blood count (red blood cell, hemoglobin, hematocrit, leukocyte, platelet), uric acid, Amy
8. change of specific test values from baseline
- blood test values: NT-proBNP, erythropoietin, reticulocyte
- urine test values: urinary albumin/creatinine ratio, urinary creatinine
9. change of OHA-Q (questionnaire for patients QOL) score from baseline
10. change of waist circumference and BMI from baseline
11. frequency of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A: Administration of luseogliflozin
Interventions/Control_2 Group B: Administration of DPP-4 inhibitors
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.
1. type 2 diabetes mellitus patients.
2. Male and female patients who are at age of 20 years or older when giving their consent.
3. Patients who did not use antidiabetic medication within 8 weeks before consenting, or patients who used anti-diabetic therapeutic agents other than SGLT2 inhibitors and DPP-4 inhibitors* and who did not change the usage and the dose of them within 8 weeks before consenting. * including once-weekly DPP-4 inhibitors.
4. Patients with HbA1c 7.0% or higher but no more than 8.5% within 12 weeks before consenting.
5. Patients with BMI 22 kg/m2 or higher.
6. Patients who can give their consent in a written form.
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
1. Type 1 diabetes mellitus or secondary diabetes
2. Patients who used insulin, GLP-1 analogs, or SU within 8 weeks before consenting
3. Patients who had myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent
4. Patients with severe liver disease (Patients with AST or ALT value five times or more of the upper limit of the stand value in each research institution)
5. Patients with serious renal disease (eGFR less than 30 mL/min/1.73m2)
6. Patients with unstable hypertension and dyslipidemia
7. Dehydrated patients (patients complain to have a symptom of dehydration)
8. Patients with urinary tract infection or genital infection
9. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
10. Contraindication: patients with hypersensitivity to any medical component of each study drug
11. Patients who need legal representative for giving consent
12. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Sugawara
Organization Japan Physicians Association
Division name Academic Committee
Zip code
Address Tokyo Medical Association building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, Japan
TEL 03-3259-6111
Email ms@sugawara.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo, Japan
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Japan Physicians Association
Institute
Department

Funding Source
Organization Taisho Toyama Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 11 Month 27 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 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
2017 Year 11 Month 27 Day
Last modified on
2018 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034400

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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