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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Type 2 diabetes mellitus | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
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Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
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Last modified on |
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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 |