UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031867
Receipt number R000035106
Scientific Title The Effect of SGLT2 inhibitor Tofogliflozin to Quality of Life of Patients with Type 2 Diabetes Mellitus Research
Date of disclosure of the study information 2018/03/26
Last modified on 2019/02/12 10:17:44

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Basic information

Public title

The Effect of SGLT2 inhibitor Tofogliflozin to Quality of Life of Patients with Type 2 Diabetes Mellitus Research

Acronym

The Effect of SGLT2 inhibitor Tofogliflozin to Quality of Life of Patients with Type 2 Diabetes Mellitus Research (SGITR study)

Scientific Title

The Effect of SGLT2 inhibitor Tofogliflozin to Quality of Life of Patients with Type 2 Diabetes Mellitus Research

Scientific Title:Acronym

The Effect of SGLT2 inhibitor Tofogliflozin to Quality of Life of Patients with Type 2 Diabetes Mellitus Research (SGITR 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

This study is aimed to investigate the effect of SGLT2 ihibitor tofogliflozin to the change of quality of life (QOL) such as treatment satisfaction, by adding it to under-controlled patients with type 2 diabetes mellitus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in the diabetes treatment satisfaction measured by DTSQ after 12 month of adding tofogliflozin.

Key secondary outcomes

1) Change in the diabetes treatment satisfaction measured by DTSQ after 3 month of adding tofogliflozin.
2) Change in the eating behavior survey, the food frequency survey, the QOL self-administered questionnaire, and International Prostate Symptom Score.
3) Correlation between the change in the quality of life and the glycemic control, the body weight and the body composition.
4) Correlation between the change in the eating behavior and the glycemic control, the body weight and the body composition.
5) Correlation between the change in the energy intake and the glycemic control, the body weight and the body composition.
6) Change in the markers of the glycemic control, blood sample analysis, body composition, capability to secrete insulin, special blood sample analysis, urine sample analysis and medication adherence.


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

Tofogliflozin 20mg/day.

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients with type 2 diabetes mellitus.
2) Patients using DPP-4 inhibitor and/or sulfonyl urea and/or insulin for 3 month or more prior to the moment of starting tofogliflozin.
3) Patients with the HbA1c levels of 7.0% or more, and less than 10.0%, at the moment of starting tofogliflozin.
4) Patients aged 20 years old or more, and less than 75 years old at the moment of starting tofogliflozin.
5) Patients who provided written informed consent.

Key exclusion criteria

1) Patients using pharmaceuticals to treat diabetes mellitus other than DPP-4 inhibitor and sulfonyl urea and insulin (including GLP-1 receptor agonist) for 3 month or more prior to the moment starting tofogliflozin.
2) Patients with the serum creatinine levels of 2.0 mg/dl or more.
3) Patients with hypothyroidism.
4) Patients with hyperthyroidism.
5) Patients with BMI less than 18.5 kg/m2, or 40 kg/m2 or more.
6) Patients who have allergy to tofogliflozin.
7) Patients with severe ketosiss, diabetic coma or impending diabetic coma.
8) Patinets with severe infection, in perioperative period, or with severe trauma.
9) Patients to whom participating this study is considered to be inappropriate for any reason.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Murata

Organization

NHO Kyoto Medical Center

Division name

Diabetes Center

Zip code


Address

1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan

TEL

075-641-9161

Email

murata-tky@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Murata

Organization

NHO Kyoto Medical Center

Division name

Diabetes Center

Zip code


Address

1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan

TEL

075-641-9161

Homepage URL


Email

murata-tky@umin.net


Sponsor or person

Institute

NHO Kyoto Medical Center, Diabetes Center

Institute

Department

Personal name



Funding Source

Organization

Kowa Company, Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

国立病院機構京都医療センター(京都府)(NHO Kyoto Medical Center)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 26 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

Terminated

Date of protocol fixation

2018 Year 01 Month 30 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 26 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

2018 Year 03 Month 23 Day

Last modified on

2019 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name