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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010468
Receipt No. R000012232
Scientific Title Effect of alogliptin on diavetic vascular complication
Date of disclosure of the study information 2013/07/01
Last modified on 2019/03/11

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Basic information
Public title Effect of alogliptin on diavetic vascular complication
Acronym Effect of alogliptin on diavetic vascular complication
Scientific Title Effect of alogliptin on diavetic vascular complication
Scientific Title:Acronym Effect of alogliptin on diavetic vascular complication
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the effect of alogliptin on the progression of atherosclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Flow mediated vasodilatation, urinary nephrin excretion
Key secondary outcomes urinary albumin excretion, estimated GFR,circulating CD34+ cell, high sensitive CRP, IL-6, small dense LDL-C

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 alogliptin
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 HbA1c level is above 6.5%
Key exclusion criteria 1) insulin therapy
2)started angiotensin converting enzyme inhibitor, angiotensin receptor blocker, statin, pioglitazon within three monthes
3) pregnancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Makino
Organization National Cerebral and cardiovascular Center
Division name Endocrinology and Metabolism
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
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 Endocrinology and Metabolism
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email makinoh@hsp.ncvc.go.jp

Sponsor
Institute Alogliptin study group
Institute
Department

Funding Source
Organization none
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
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 国立循環器病研究センター

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2011 Year 07 Month 01 Day
Date of IRB
2011 Year 07 Month 29 Day
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2013 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 11 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012232

Research Plan
Registered date File name
2017/04/14 ネシーナ研究(研究計画書)槇野.docx

Research case data specifications
Registered date File name
2017/04/14 ケースカード(ネシーナ研究).doc

Research case data
Registered date File name


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