UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017180 |
|---|---|
| Receipt number | 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 15:09:26 |
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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
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
C-aoki@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019934
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
