UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032005
Receipt No. 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

* 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 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
Institute Nishitokyo Diabetes Research Group of Specified Nonprofit Organization
Institute
Department

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
URL(English) https://upload.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


Contact us.