UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031867
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.