UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of anti oxidative effect of linagliptin on type 2 diabetic patients.
Title of the study (Brief title)	Evaluation of anti oxidative effect of linagliptin on type 2 diabetic patients.
Region	Japan

Condition
Condition	type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify anti oxidative effect of linagliptin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of MDA-LDL colesterol and urinary 8OHdG
Key secondary outcomes	Change of high sensitive CRP and urinary LFABP

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	5mg of linagliptin
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 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes patients
Key exclusion criteria	Patients who started renin angiotensin system inhibitor, statin, and/or pioglitazon within 1 month
Target sample size	30

Research contact person
Name of lead principal investigator	Hisashi Makino
Organization	National cerebral and cardiovascular center
Division name	Division of endocrinology and metabolism
Address	5-7-1 Fujisirodai, Suita, Osaka, Japan
TEL	06-6733-5012
Email	makinoh@hsp.ncvc.go.jp

Public contact
Name of contact person	Hisashi Makino
Organization	National cerebral and cardiovascular center
Division name	Division of endocrinology and metabolism
Address	5-7-1 Fujisirodai, Suita, Osaka, Japan
TEL	06-6733-5012
Homepage URL
Email	makinoh@hsp.ncvc.go.jp

Sponsor
Institute	linagliptin study group
Institute
Department

Funding Source
Organization	Japan cardiovascular research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 13 Day
Anticipated trial start date	2014 Year 01 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	Published
URL releasing results
Results
Other related information	Twenty one patients were entolled, and 15 patients were finished obsebation period.

Management information
Registered date	2014 Year 10 Month 01 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017806