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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030172
Receipt No. R000034463
Scientific Title The efficacy and the safety of the DPP4 inhibitor in patients with type 2 diabetes complicated with renal dysfunction
Date of disclosure of the study information 2017/11/30
Last modified on 2017/11/29

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Basic information
Public title The efficacy and the safety of the DPP4 inhibitor in patients with type 2 diabetes complicated with renal dysfunction
Acronym The efficacy and the safety of the DPP4 inhibitor in patients with type 2 diabetes complicated with renal dysfunction
Scientific Title The efficacy and the safety of the DPP4 inhibitor in patients with type 2 diabetes complicated with renal dysfunction
Scientific Title:Acronym The efficacy and the safety of the DPP4 inhibitor in patients with type 2 diabetes complicated with renal dysfunction
Region
Japan

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

Objectives
Narrative objectives1 To compare an efficacy of medical treatment using each kind of DPP4 inhibitor of diabetes with renal dysfunction in point of view the effectiveness and the safety
Basic objectives2 Others
Basic objectives -Others safety, efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of HbA1c(%), glycoalbumin(%), adverse event, serum creatinine(mg/dL), eGFR(mL/min/1.73m2),urinary protain/creatinine rate(mg/gCre) and urinary albumin/creatinine ratio(mg/gCre) from baseline to end of treatment and the actual self-pay and evaluation of the patient to it at 48week later from an examination start
Key secondary outcomes Change of BW, liver function at 48week later from an examination start

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After the dosing for 24 weeks DPP4 inhibitor not requiring capacity adjustment by kidney function, we administer a dose for 24 weeks DPP4 inhibitor requiring capacity adjustment by kidney function.
The patient take blood test and examination every 12 weeks.
Interventions/Control_2 After the dosing for 24 weeks DPP4 inhibitor requiring capacity adjustment by kidney function, we administer a dose for 24 weeks DPP4 inhibitor not requiring capacity adjustment by kidney function.
The patient take blood test and examination every 12weeks.
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)Type 2 diabetes patients who take DPP4 inhibitor with following 2) or 3).
2)Diabetic nephropathy stage is over II or more.
3)eGFR <60 mL/min/1.73 m2
Key exclusion criteria 1)Contraindicated patient in the attached document of each DPP4 inhibitors
2)Investigator concludes that the patient's participation in this study is inappropriate
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Santou
Organization Osaka Saiseikai Noe Hospital
Division name Department of Diabetes and Endocrinology
Zip code
Address 1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL 06-6932-0401
Email santou@noe.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Santou
Organization Osaka Saiseikai Noe Hospital
Division name Department of Diabetes and Endocrinology
Zip code
Address 1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL 06-6932-0401
Homepage URL
Email santou@noe.saiseikai.or.jp

Sponsor
Institute Osaka Saiseikai Noe Hospital
Institute
Department

Funding Source
Organization Osaka Saiseikai Noe Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 大阪府済生会野江病院(大阪府)/Osaka Saiseikai Noe Hospital (Osaka)

Other administrative information
Date of disclosure of the study information
2017 Year 11 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 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
2017 Year 11 Month 29 Day
Last modified on
2017 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034463

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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