UMIN-CTR Clinical Trial

Public title

The differences in blood glucose management and affects on cardiac function of SGLT2 and DPP4 inhibitors

Acronym

The differences between SGLT2 and DPP4 inhibitors in cardiac function

Scientific Title

The differences in blood glucose management and affects on cardiac function of SGLT2 and DPP4 inhibitors

Scientific Title:Acronym

The differences between SGLT2 and DPP4 inhibitors in cardiac function

Region

Japan

Condition

Diabetes mellitus (DM) patients complicated with heart failure preserved ejection fraction (HFpEF)

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The evaluation of blood glucose management and cardiac function in patients with DM and HFpEF

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Presence or absence of total/cardiovascular death, re-hospitalization of HF and worsening of DM

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

If blood glucose management with patients who were administrated with DPP4 inhibitor were more bad, strict diet exercise therapy is performed and DPP4 inhibitor is continued.
DPP4 inhibitors or SGLT2 inhibitors will be continue for 6 months after the change, however, we stop this examination if blood glucose manegement exacerbation will apear.

Interventions/Control_2

If blood glucose management with patients who were administrated with DPP4 inhibitor were more bad, strict diet exercise therapy is performed and DPP4 inhibitor is switched to SGLT2 inhibitor.
DPP4 inhibitors or SGLT2 inhibitors will be continue for 6 months after the change, however, we stop this examination if blood glucose manegement exacerbation will apear.

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

30

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Outpatients with DM and HFpEF of NHYA classification of I - III
Medications (including DPP4 inhibitor) did not changed of dosage before 4 weeks from examincation start
Blood glucose management were worsening and patients who need to strict diet/exercise therapy or change medication.

Key exclusion criteria

Pregnancy, breast-feeding, patients who may be pregnant, and patients who want pregnancy during the examination
Patients who may be thought to worse blood glucose management with the protocol of this examination.
Patients who are received with DPP 4 inhibitor, once a week.
Patients with moderate or severe renal impairment (less than eGFR 45)
Patients with severe hepatic impairment (Child-Pugh classification C)
Patients who were judged inappropriate as subjects of this examination by investigators

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Shunsuke Kiuchi

Organization

Toho University Omori Medical Center

Division name

Department of Cardiovascular Medicine

Zip code

Address

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541

TEL

03-3762-4151

Email

syunnsuke@med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shunsuke Kiuchi

Organization

Toho University Omori Medical Center

Division name

Department of Cardiovascular Medicine

Zip code

Address

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541

TEL

03-3762-4151

Homepage URL

Email

syunnsuke@med.toho-u.ac.jp

Institute

Toho University

Institute

Department

Personal name

Organization

Toho University Omori Medical Center, Department of Cardiovascular Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2018

Year

04

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2018

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

04

Month

16

Day

Last modified on

2018

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036800