UMIN-CTR Clinical Trial

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

* 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

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


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



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 or person

Institute

Regulatory mechanism of body composition through SGLT2 study group

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017530


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name