UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 11 Month 29 Day
Date of IRB	2017 Year 12 Month 27 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date	2019 Year 09 Month 10 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 11 Month 29 Day
Last modified on	2020 Year 12 Month 01 Day

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