UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030172 |
|---|---|
| Receipt number | 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 | 2020/12/01 14:41:01 |
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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
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
santou@noe.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Noe Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
