Unique ID issued by UMIN | UMIN000015112 |
---|---|
Receipt number | R000017530 |
Scientific Title | A study of Luseogliflozin : the components of weight loss in the Japanese patients with type 2 diabetes mellitus |
Date of disclosure of the study information | 2014/09/10 |
Last modified on | 2017/01/06 11:20:21 |
A study of Luseogliflozin : the components of weight loss in the Japanese patients with type 2 diabetes mellitus
LIGHT
A study of Luseogliflozin : the components of weight loss in the Japanese patients with type 2 diabetes mellitus
LIGHT
Japan |
patients with type 2 diabetes mellitus
Medicine in general | Endocrinology and Metabolism |
Others
NO
Consideration of weight fluctuation at the time of the administration of luseogliflozin hydrate (selective SGLT2 inhibitor) in Japanese patients with type 2 diabetes mellitus and its causes
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Weight, amounts of fat and fat-free mass by DXA as well as fluctuations in composition estimated from amounts of subcutaneous fat and visceral fat by CT scan
- Glycemic control
- Degree of obesity
- Lipid parameter
- Blood pressure
- QOL
- Adverse events and adverse reaction incidence
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oral luseogliflozin 2.5 mg once daily after breakfast and before breakfast
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1) Patients with HbA1c (NGSP value) between 7.0% and 10.5% at the time of informed consent.
2) Patients who have been receiving specific diet for more than 8 weeks at the time of initiation of luseogliflozin.
3) Patients who have not taken any antidiabetes agents for more than 8 weeks or have been taking one oral hypoglycemic agent at the same dose.
4) Patients with BMI between 20.0 and 35.0 at the time of informed consent.
5) Patients (regardless of gender) who are aged 20 to 65 at the time of informed consent.
6) Outpatients
7) Patients who can receive an explanation before the participation in the study understand the contents and provide written informed consents by themselves.
1) Patients with diabetes mellitus other than type 2 diabetes mellitus (type 1 diabetes mellitus, diabetes mellitus due to specific mechanism/ diseases other than type 2 and gestational diabetes, etc.)
2) Patients with severe renal impairment (nephrotic syndrome, renal failure and dialysis procedure, etc.)
3) Patients with severe hepatic dysfunction (hepatic cirrhosis, etc.)
4) Patients with severe cardiac disorder (cardiac failure, etc.), myocardial infarction and cerebral infarction or a previous history of these diseases within 6 months prior to the study
5) Patients with severe diabetic microangiopathy (despite continuous treatment, inadequately-controlled diabetic retinopathy and diabetic neuropathy, etc.)
6) Patients with malignant tumour or a previous history of malignant tumour (however, included those who were not treated for them, do not have recurrence and will not have a recurrence during the study can be included).
7) Patients who have a previous history of hypersensitivity to luseogliflozin
8) Severe chronic drinkers
9) Pregnant or possibly pregnant women, women who hope to be pregnant and lactating women during the study
10) Those considered inappropriate for the study by physicians in charge of the study
48
1st name | |
Middle name | |
Last name | 1)Takashi Sasaki 2)Masahiro Sugawara 3)Masahiro Fukuda |
1)Institute of Clinical Medicine and Research, Research Center for Medical Sciences, The Jikei University School of Medicine 2) Sugawara Clinic 3)FUKUDA CLINIC
1)Professor 2)Director 3)Director
1)163-1, Kashiwashita, Kashiwa-shi Chiba 277-8567 Japan 2)3-9-16, Kamisyakujii, Nerima-ku, Tokyo, Japan 3)Shin-osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka, Japan
04-7164-1111
takashi_sasaki@jikei.ac.jp
1st name | |
Middle name | |
Last name | Yosuke Sawa |
QOL RD Co., Ltd.
EBM Division
Front Place Nihonbashi Bldg, 2-14-1, Nihonbashi, Chuo-ku, Tokyo, Japan
03-6386-9500
http://www.light-study.net/
light-info@qol-rd.co.jp
Regulatory mechanism of body composition through SGLT2 study group
TAISHO TOYAMA PHARMACEUTICAL CO., LTD.
Profit organization
NO
2014 | Year | 09 | Month | 10 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 29 | Day |
2014 | Year | 09 | Month | 10 | Day |
2014 | Year | 09 | Month | 10 | Day |
2017 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017530
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