UMIN-CTR Clinical Trial

Public title

Examination of the effect by taking the sodium glucose transporter 2 inhibitor everyday or only when a patient thinks it to be necessary for type 2 diabetes patients controlled inadequately.

Acronym

Empagliflozin taken as needed improves patient's therapeutic motivation and quality of life(QOL)with lowering HbA1c and body weight.

Scientific Title

Examination of the effect by taking the sodium glucose transporter 2 inhibitor everyday or only when a patient thinks it to be necessary for type 2 diabetes patients controlled inadequately.

Scientific Title:Acronym

Empagliflozin taken as needed improves patient's therapeutic motivation and quality of life(QOL)with lowering HbA1c and body weight.

Region

Japan

Condition

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For type 2 diabetes patients controled inadequately with HbA1c 7.0 to 9.9%,taking oral anti-diabetic drugs to diet and exercise therapy for 12 weekes or more,the sodium glucose transporter 2 inhibitor(Empagliflozin 10mg) will be added everyday or only when a patient thinks it to be necessary.It is intended to be compared the incidence of adverse events such as dehydration,usefulness in grycemic control,effects on therapeutic motivation and quality of life(QOL) between two groups.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.a reduction degree of the HbA1c and fasting plasma glucose 12 or 24 weeks later

Key secondary outcomes

2.changes of dietary intake 12 or 24 weeks later
3.changes of quality of life(QOL) 12 or 24 weeks later
4.a reduction degree of lipid parameters(HDL cholesterol･LDL cholesterol･triglyceride) and albumin in urine 12 or 24 weeks later
5.changes of body weight,blood pressure, and abdominal circumscription 12 or 24 weeks later

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

The group which Empagliflozin 10mg every day for 12 weeks or 24 weeks.

Interventions/Control_2

The group which takes Empagliflozin 10mg only when a patient thinks it to be necessary at the maximum 14 times a month for 12 weeks or 24 weeks.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Type 2 diabetes patients controlled inadequately with 7.0 to 9.9%.
(2)Patient taking equal or less than three kinds of oral anti-diabete drugs in addition to diet and exercise therapy for 12 weeks or more.
(3)Patients who does not use human GLP-1 analog or insulin.
(4)Adalts who are 20 years or older and 75 years or younger.
(5)Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in examination.

Key exclusion criteria

(1) Type 1 diabetes mellitus patients or secondary diabetic mellitus.
(2) Patients who had myocardial infarction within 3 months, or obvious heart failure case.
(3) Patients who had the past hypersensitivity for the used drug.
(4) Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma.
(5) Patients with severe liver disease.
(6) Patients with severe renal disease.
(7) Patients with severe pancreas disease.
(8) Patients with hemoglobin (Hb) less than 11 g/dL.
(9) Patient during cancer treatment
(10) Patients that the number of the platelets is less than 100,000 /mm3.
(11) Patients with severe diabetic neuropathy.
(12) Patients having a proliferative retinopathy.
(13) Patients with a serious infectious disease or a serious injury.
(14) Excessive common custom drinker
(15) A pregnant woman or the woman who may be pregnant.
(16) In addition, the patients who will be judged inappropriate by an attendant physician.

Target sample size

50

Name of lead principal investigator

1st name	Takahisa
Middle name
Last name	Hirose

Organization

Toho University School of Medicine

Division name

Division of diabetes, metabolism and endocrinology

Zip code

143-8541

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

03-3762-4151

Email

takahisa.hirose@med.toho-u.ac.jp

Name of contact person

1st name	Takahisa
Middle name
Last name	Hirose

Organization

Toho University School of Medicine

Division name

Division of diabetes, metabolism and endocrinology

Zip code

143-8541

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

03-3762-4151

Homepage URL

Email

takahisa.hirose@med.toho-u.ac.jp

Institute

Toho University School of Medicine, Division of diabetes, metabolism and endocrinology

Institute

Department

Personal name

Organization

Toho University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

ethics committee of Toho University school if medicine

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan

Tel

03-3762-4151

Email

oomori.rinri@ex.toho-u.ac.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

2015

Year

10

Month

06

Day

URL releasing protocol

DOI: 10.1111/dom.13524

Publication of results

Published

URL related to results and publications

DOI: 10.1111/dom.13524

Number of participants that the trial has enrolled

50

Results

HbA1c decreased significantly in the intermittent treatment group and the reduction was similar to that observed in the regular
treatment group. As the reason, energy intake decreased significantly only in the intermittent group. So, intermittent empagliflozin supplementation was thought to be a useful therapeutic option that empowers dietary self-management.

Results date posted

2022

Year

10

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We enrolled type 2 diabetes treated for >12 weeks with fewer than three types of oral glucose-lowering agents, in addition
to diet and exercise. Mean age was 54.4, BMI was 27.9, HbA1c was 8.1%.

Participant flow

A total of 50 patients were enrolled in this study. They were randomized into an intermittent (n = 25) and a regular treatment group (n = 25). Five of the participants withdrew agreement. A total of 44 participants completed the study, but the FAS population included 22 participants in the intermittent group and 16 in the regular treatment group after exclusion of participants with significant study protocol violation.

Adverse events

The most frequently reported AE was pollakiuria. No participant in either group discontinued the study as a result of an AE.

Outcome measures

The primary endpoint of this study was the change of HbA1c after 24-week treatment. Furthermore, we also assessed the change of body weight, energy intake, and QOL.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2015

Year

09

Month

17

Day

Date of IRB

2015

Year

07

Month

27

Day

Anticipated trial start date

2015

Year

10

Month

06

Day

Last follow-up date

2017

Year

02

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

06

Day

Last modified on

2022

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022080