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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026887
Receipt No. R000030803
Scientific Title The effect of SGLT2 inhibitor on glomrular hyperfiltration in type 2 diabetes patients.
Date of disclosure of the study information 2017/04/09
Last modified on 2019/04/15

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Basic information
Public title The effect of SGLT2 inhibitor on glomrular hyperfiltration in type 2 diabetes patients.
Acronym The effect of SGLT2 inhibitor on glomrular hyperfiltration
Scientific Title The effect of SGLT2 inhibitor on glomrular hyperfiltration in type 2 diabetes patients.
Scientific Title:Acronym The effect of SGLT2 inhibitor on glomrular hyperfiltration
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of SGLT2 inhibitor on glomerular hyperfiltration in type 2 diabetes patients treated with DPP4 inhibitor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
GFR(measure with inulin clearance)
Key secondary outcomes

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 administration of 2.5 mg luseogliflozin once a day, pre or post breakfast for 52 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.HbA1c>=7.0%
2.Patients who have received treatment of type 2 diabetes mellitus(diet therapy, exercise therapy and so on)
3.eGFR>=100 ml/min/1.73m2
4.Patients who have received DPP4 inhibitor dose of them are stable over 8 weeks.
5.Age >= 20 years and Male and Female
6.Outpatients
7.Consent to study participation has been obtained in writing from the patient personally
Key exclusion criteria 1. The amount of change of eGFR between screening and initiation of study is more than 10ml/min/1.73m2
2. Patient with type 1 diabetes mellitus or with history of secondary diabetes mellitus
3. Patients with history of or concurrent complication that affect renal function(renal disease, nephrotic syndrome and so on)or patients with dialysis
4. Patients with the history of serious hepatic diseases.
5. Patients with history of myocardial infarction, congestive heart failure, unstable angina, cerebrovascular disease within 6 months prior to screening visit (confirmation of eligibility)
6. Patients with history of or concurrent complication that affect digestive function
7. Patients with the history of serious diabetic complications requiring treatment
8. Patients with history of malignant tumor
9. Patients with a history of drug allergies that interfere with participation in the clinical trial.
10. Patients suspected of alcohol or drug abuse.
11. Pregnant women, nursing mothers, or patients who do not agree to contraception during study period.
12. Patients with diabetes receiving SGLT2 inhibitor in the 8 weeks prior to screening period.
13. Patients who are judged as inappropriate by investigators on screening examination.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Katsushige
Middle name
Last name Abe
Organization Abe Diabetes Clinic
Division name internal medicine
Zip code 870-0039
Address 16-13 nakakasuga,Oita
TEL 097-538-1633
Email rukonyan@ga2.so-net.ne.jp

Public contact
Name of contact person
1st name Katsushige
Middle name
Last name Abe
Organization Abe Diabetes Clinic
Division name internal medicine
Zip code 870-0039
Address 16-13 nakakasuga,Oita
TEL 097-538-1633
Homepage URL
Email rukonyan@ga2.so-net.ne.jp

Sponsor
Institute Abe Diabetes Clinic
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 内科阿部医院(大分)、白岩内科医院(大阪)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 09 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 10
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
2017 Year 01 Month 25 Day
Date of IRB
2016 Year 12 Month 08 Day
Anticipated trial start date
2017 Year 04 Month 10 Day
Last follow-up date
2019 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 06 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030803

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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