UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032005
Receipt number R000036078
Scientific Title Investigation on Renal Protective Effect by Luseogliflozin
Date of disclosure of the study information 2018/03/30
Last modified on 2019/04/09 10:21:44

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Basic information

Public title

Investigation on Renal Protective Effect by Luseogliflozin

Acronym

Investigation on Renal Protective Effect by Luseogliflozin

Scientific Title

Investigation on Renal Protective Effect by Luseogliflozin

Scientific Title:Acronym

Investigation on Renal Protective Effect by Luseogliflozin

Region

Japan


Condition

Condition

Patients with type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of Luseogliflozin on eGFR change and renal function in the long term administration of Luseogliflozin to patients with type 2 diabetes mellitus as the subject.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

eGFR variation before and after therapy at Week 48

Key secondary outcomes

Variations of the following items before and after therapy at Week 48
1)Physical findings
Body weight, BMI, blood pressure, pulse pressure, mean arterial pressure, pulse
2)Hematologic examination
HbA1c, fasting blood glucose level, ketone body fraction (acetoacetic acid, 3-hydroxybutyric acid, total ketone body)
3)Urinalysis
Urinary albumin/creatinine ratio, urine sugar (qualitative)
4)Double product


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

Luseogliflozin 2.5 mg will be administered once a day for 48 weeks. In principle, 2.5 mg as Luseogliflozin will be administered once a day, but if the principal investigator or co-investigator judges that efficacy is insufficient, increase to 5 mg once a day is permissible.

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)A patient whose eGFR is less than 60 mL/min/1.73 m2
2)A patient aged 65 years or older
3)A patient whose HbA1c is 6.5% or more but less than 9.0%
4)A patient from whom written informed consent on his/her participation in this study can be obtained directly

Key exclusion criteria

1)A patient with type 1 diabetes
2)A patient who received an SGLT2 inhibitor within 8 weeks before the start of the treatment phase
3)A patient with severe ketosis, diabetic coma, or precoma
4)A patient with severe infections, before and after surgery, serious trauma
5)A patient with a medical history of hypersensitivity to components of SGLT2 inhibitors
6)A patient with pituitary gland dysfunction or adrenal gland dysfunction
7)A patient showing poor nutritional status, starvation status, irregular meal intake, insufficient dietary intake, or hyposthenia
8)A patient with a medical history of urinary tract infections due to urinary outflow disorder, etc., a patient with a medical history of severe genital infection, or patients currently infected
9)A patient who is prone to dehydration
10)A patient with severe renal dysfunction or a patient with end-stage renal failure during dialysis
11)A patient who is judged unsuitable for participation in this study by his/her attending physician

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Kitaoka

Organization

IMS Miyoshi General Hospital

Division name

Endocrine & Metabolism Center

Zip code


Address

974-3, Fujikubo, Miyoshi-machi, Iruma-gun, Saitama

TEL

049-258-2323

Email

masa_kitaoka@mrc.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masafumi Kitaoka

Organization

IMS Miyoshi General Hospital

Division name

Endocrine & Metabolism Center

Zip code


Address

974-3, Fujikubo, Miyoshi-machi, Iruma-gun, Saitama

TEL

049-258-2323

Homepage URL


Email

masa_kitaoka@mrc.biglobe.ne.jp


Sponsor or person

Institute

Nishitokyo Diabetes Research Group of Specified Nonprofit Organization

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

社会医療法人財団大和会東大和病院(東京都)
医療法人社団桜一会かんの内科(東京都)
医療法人社団明芳会イムス三芳総合病院(埼玉県)
医療法人社団南山寿会中島内科クリニック(東京都)
医療法人社団ユスタヴィア多摩センタークリニックみらい(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 30 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

30

Results

The study is not registered to UMIN because the specific clinical research studies are registered and released to jRCT due to the Clinical Research Law enforcement.

Results date posted

2019 Year 04 Month 09 Day

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

Terminated

Date of protocol fixation

2018 Year 01 Month 23 Day

Date of IRB

2018 Year 02 Month 22 Day

Anticipated trial start date

2018 Year 03 Month 31 Day

Last follow-up date

2020 Year 06 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 30 Day

Last modified on

2019 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name