UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of Teneligliptin on endothelial function in type 2 diabetes mellitus with chronic kidney disease
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kunihiro Suzuki
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880, Kitakobayashi, Shimotugagun, Mibu, Tochigi
TEL	0282-87-2150
Email	kuni-s@dokkyomed.ac.jp

Public contact
Name of contact person	Chie Aoki
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://cardiab.biomedcentral.com/articles/10.1186/s12933-016-0396-3
Results
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