UMIN-CTR Clinical Trial

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
Institute	NHO Kyoto Medical Center, Diabetes Center
Institute
Department

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
URL(English)	https://upload.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

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