UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015308
Receipt number R000017806
Scientific Title Evaluation of anti oxidative effect of linagliptin on type 2 diabetic patients.
Date of disclosure of the study information 2014/10/01
Last modified on 2018/10/04 09:25:48

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Basic information

Public title

Evaluation of anti oxidative effect of linagliptin on type 2 diabetic patients.

Acronym

Evaluation of anti oxidative effect of linagliptin on type 2 diabetic patients.

Scientific Title

Evaluation of anti oxidative effect of linagliptin on type 2 diabetic patients.

Scientific Title:Acronym

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

1st name
Middle name
Last name Hisashi Makino

Organization

National cerebral and cardiovascular center

Division name

Division of endocrinology and metabolism

Zip code


Address

5-7-1 Fujisirodai, Suita, Osaka, Japan

TEL

06-6733-5012

Email

makinoh@hsp.ncvc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Makino

Organization

National cerebral and cardiovascular center

Division name

Division of endocrinology and metabolism

Zip code


Address

5-7-1 Fujisirodai, Suita, Osaka, Japan

TEL

06-6733-5012

Homepage URL


Email

makinoh@hsp.ncvc.go.jp


Sponsor or person

Institute

linagliptin study group

Institute

Department

Personal name



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)



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

2014 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


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

2013 Year 12 Month 13 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017806


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name