UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of blood glucose and serum lipids lowring effects of teneligliptin in patients with type 2 diabetes mellitus
Title of the study (Brief title)	Effects of teneligliptin on blood glucose and serum lipids profile
Region	Japan

Condition
Condition	Patients with type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of blood glucose and serum lipids lowring effects of trneligliptin in patients with type 2 diabetes mellitus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure, LDL-c
Key secondary outcomes	HbA1c, blood glucose, u-Na, s-Na, s-Cr, u-Cr, NT-proBNP, IRI, ANP, sLDL, metylglyoxal, CRP

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	teneligliptin 20mg per day for 12weeks
Interventions/Control_2
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 months-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1:Patient with written concent for participation in this study 2:male and female 3:20 y.o or older 4:in- and out-patient
Key exclusion criteria	1:contrandication to teneligliptin 2:Ineligible for this study
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroyuki Ariyasu
Organization	Wakayama medical University
Division name	First department of internal medicine
Address	811-1, KImiidera, Wakayama, Japan, 641-8509
TEL	073(447)2300
Email	ariyasu@wakayama-med.ac.jp

Public contact
Name of contact person	Hiroyuki Ariyasu
Organization	Wakayama medical University
Division name	First department of internal medicine
Address	811-1, KImiidera, Wakayama, Japan, 641-8509
TEL	073(447)2300
Homepage URL
Email	ariyasu@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical University
Institute
Department

Funding Source
Organization	First department of internal medicine, WAkayama Medical 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	2013 Year 11 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 21 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 04 Day
Last modified on	2017 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014274