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Recruitment status Completed
Unique ID issued by UMIN UMIN000015112
Receipt No. 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

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Basic information
Public title A study of Luseogliflozin : the components of weight loss in the Japanese patients with type 2 diabetes mellitus
Acronym LIGHT
Scientific Title A study of Luseogliflozin : the components of weight loss in the Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym LIGHT
Region
Japan

Condition
Condition patients with type 2 diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 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
Key secondary outcomes - Glycemic control
- Degree of obesity
- Lipid parameter
- Blood pressure
- QOL
- Adverse events and adverse reaction incidence

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Oral luseogliflozin 2.5 mg once daily after breakfast and before breakfast
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)Takashi Sasaki 2)Masahiro Sugawara 3)Masahiro Fukuda
Organization 1)Institute of Clinical Medicine and Research, Research Center for Medical Sciences, The Jikei University School of Medicine 2) Sugawara Clinic 3)FUKUDA CLINIC
Division name 1)Professor 2)Director 3)Director
Zip code
Address 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
TEL 04-7164-1111
Email takashi_sasaki@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Sawa
Organization QOL RD Co., Ltd.
Division name EBM Division
Zip code
Address Front Place Nihonbashi Bldg, 2-14-1, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL 03-6386-9500
Homepage URL http://www.light-study.net/
Email light-info@qol-rd.co.jp

Sponsor
Institute Regulatory mechanism of body composition through SGLT2 study group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization TAISHO TOYAMA PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 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 Completed
Date of protocol fixation
2014 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 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
2014 Year 09 Month 10 Day
Last modified on
2017 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017530


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