UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016635
Receipt number R000019290
Scientific Title Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients
Date of disclosure of the study information 2015/03/01
Last modified on 2020/01/10 14:34:18

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Basic information

Public title

Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients

Acronym

SGLT2 Study

Scientific Title

Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients

Scientific Title:Acronym

SGLT2 Study

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm and describe the main factors of weight loss even in Japanese is the reduction of body fat
To weigh and describe the correlations between each items such as body weight, abdominal circumference, body fat, HbA1c, visceral fat, blood pressure, adiponectin, and insulin resistance

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

HbA1c ,FPG ,Body weight ,Body mass index ,Body fat

Key secondary outcomes

Visceral fat area ,Waist circumference ,Amount of body fat distribution ,Lean body weight ,HOMA-IR ,HOMA-b ,iHOMA2 ,Blood pressure ,Lipid ,Uric acid ,eGFR ,GIR ,Liver function ,Renal function ,Adiponectin ,TNFa ,IL-6 ,NTpro-BNP


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

Take CANAGLU Tablets 100mg at the oral.
1tablet/day
Period of 24 weeks
Conducted blood sampling and body fat,abdominalCT ,etc. before and after intervention.

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


Not applicable

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Informed consent obtained in writing before any trial-related activities.
Type 2 Diabetes
Age <= 70 years old
HbA1c between 7.0% and 10.0%
BMI >= 23 kg/m2
Creatinine < 1.0mg/dL for male
< 0.8mg/dL for female

Key exclusion criteria

Extreme low carbohydrate therapy practitioner.
Considered as inappropriate by the attending physician.
A person who falls under contraindication in the medical package insert.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Shin-ichiro
Middle name
Last name Shirabe

Organization

Medical Corporation
H.E.C Science Clinic

Division name

Diabetes medicine

Zip code

235-0045

Address

4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan

TEL

045-831-0031

Email

hec-soum@asahi-net.email.ne.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Makuuchi

Organization

Medical Corporation H.E.C Science Clinic

Division name

Clinical Trial Secretariat

Zip code

235-0045

Address

4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan

TEL

045-831-0031

Homepage URL


Email

hec-soum@asahi-net.email.ne.jp


Sponsor or person

Institute

Medical Corporation
H.E.C Science Clinic

Institute

Department

Personal name



Funding Source

Organization

Mitsubishi Tanabe Pharma Corporation

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

Ethics review committee of Medical Corporation H.E.C Science Clinic

Address

4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan

Tel

045-831-0031

Email

hec-soum@asahi-net.email.ne.jp


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

医療法人社団一洋会 H.E.Cサイエンスクリニック(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 03 Month 01 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 06 Day

Date of IRB

2014 Year 08 Month 06 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2015 Year 10 Month 31 Day

Date of closure to data entry

2015 Year 11 Month 30 Day

Date trial data considered complete

2015 Year 11 Month 30 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 02 Month 25 Day

Last modified on

2020 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019290


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name