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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017180
Receipt No. R000019934
Scientific Title The effects of Teneligliptin on endothelial function in type 2 diabetes mellitus with chronic kidney disease
Date of disclosure of the study information 2015/04/20
Last modified on 2016/05/23

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Basic information
Public title The effects of Teneligliptin on endothelial function in type 2 diabetes mellitus with chronic kidney disease
Acronym Effects of Teneligliptin on endothelial function
Scientific Title The effects of Teneligliptin on endothelial function in type 2 diabetes mellitus with chronic kidney disease
Scientific Title:Acronym Effects of Teneligliptin on endothelial function
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether teneligliptin improve endothelial function, and decrease production of oxidative stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes in endothelial function and oxidative stress
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 Type 2 daiabetes mellitus with chronic kidney disease recieving sitagliptin (25-50 mg / day) treatment.
Interventions/Control_2 Type 2 daiabetes mellitus with chronic kidney disease recieving 20mg teneligliptin treatment switched from sitagliptin.
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 The study subjects were type 2 diabetes mellitus with chronic kidney disease whose hemoglobin A1c (HbA1c) was lower than 10.0% [NGSP] despite treatment with sitagliptin (25-50 mg/day) for at least 4 weeks.All patients had visited the outpatient clinic of Dkkyo Medical University
Key exclusion criteria Exclusion criteria were (1) type 1 diabetes, (2) severe complications of diabetes, (3) severe liver dysfunction (4) severe infections (5) pregnant or nursing women and those who might be pregnant (6) alcoholism, and (7) any patients whom the investigators judged to be inappropriate for this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Suzuki
Organization Dokkyo Medical University
Division name Endocrinology and Metabolism
Zip code
Address 880, Kitakobayashi, Shimotugagun, Mibu, Tochigi
TEL 0282-87-2150
Email kuni-s@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Aoki
Organization Dokkyo Medical University
Division name Endocrinology and Metabolism
Zip code
Address 880, Kitakobayashi, Shimotugagun, Mibu, Tochigi
TEL 0282-87-2150
Homepage URL
Email C-aoki@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Endocrinology and Metabolism, Dokkyo Mediacal, University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://cardiab.biomedcentral.com/articles/10.1186/s12933-016-0396-3
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
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 07 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 20 Day
Last modified on
2016 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019934

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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