UMIN-CTR Clinical Trial

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

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Masahiro
Middle name
Last name	Sugawara

Organization

Japan Physicians Association

Division name

Academic Committee

Zip code

101-0062

Address

Tokyo Medical Association building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, Japan

TEL

03-3259-6111

Email

ms@sugawara.or.jp

Name of contact person

1st name	Hiroki
Middle name
Last name	Takayama

Organization

Soiken Inc.

Division name

Clinical Study Support Division

Zip code

101-0052

Address

NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo, Japan

TEL

03-3295-1350

Homepage URL

Email

takayama@soiken.com

Institute

Japan Physicians Association

Institute

Department

Personal name

Organization

Taisho Pharmaceutical Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Japan Physicians Association Institutional Review Board

Address

Tokyo Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, 101-0062, Japan

Tel

03-3259-6177

Email

irb@nichirinnai.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

27

Day

URL releasing protocol

unpublished

Publication of results

Unpublished

URL related to results and publications

unpublished

Number of participants that the trial has enrolled

623

Results

Unpublished because the results of this study is now submitted to an academic journal

Results date posted

2023

Year

06

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Unpublished because the results of this study is now submitted to an academic journal

Participant flow

Unpublished because the results of this study is now submitted to an academic journal

Adverse events

Unpublished because the results of this study is now submitted to an academic journal

Outcome measures

<Primary endpoint>
Proportion of patients who improved three or more endpoints among five endpoints listed below from baseline to week 52 (proportion of patients who achieved the composite endpoints)
- HbA1c (change from baseline =< -0.37%)
- Weight (percent change from baseline =< -3%)
- eGFR (percent change from baseline >= -2.2%)
- systolic blood pressure (change from baseline =< -4 mmHg)
- pulse (change from baseline =< -3 bpm)

<Secondary endpoints>
1. Proportion of patients who achieved the composite endpoints from baseline to week 24
2. Change in HbA1c from baseline
3. Percent change in weight from baseline
4. Percent change in eGFR from baseline
5. Change in blood pressure from baseline
6. Change in pulse from baseline
7. Change in 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 in specific test values from baseline
- blood test values: NT-proBNP, erythropoietin, reticulocyte
- urine test values: urinary albumin/creatinine ratio, urinary creatinine
9. Change in OHA-Q (questionnaire for patients QOL) score from baseline
10. Change in waist circumference and BMI from baseline
11. Frequency of adverse events

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

10

Month

27

Day

Date of IRB

2022

Year

10

Month

15

Day

Anticipated trial start date

2018

Year

01

Month

01

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

11

Month

27

Day

Last modified on

2023

Year

06

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034400