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
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
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
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
