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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012329
Receipt No. R000013667
Scientific Title Usefulness of change to anagliptin from other DPP-4 inhibitors in patients with uncontroled LDL-cholesterol
Date of disclosure of the study information 2013/12/01
Last modified on 2015/11/19

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Basic information
Public title Usefulness of change to anagliptin from other DPP-4 inhibitors in patients with uncontroled LDL-cholesterol
Acronym Anagliptin and LDL-cholesterol
Scientific Title Usefulness of change to anagliptin from other DPP-4 inhibitors in patients with uncontroled LDL-cholesterol
Scientific Title:Acronym Anagliptin and LDL-cholesterol
Region
Japan

Condition
Condition typr 2 diabetes
hypercholesterolemia
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of change to anagliptin from other DPP-4 inhibitors in patients with uncontroled LDL-cholesterol
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL-cholesterol concentration
Key secondary outcomes

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 anagliptin
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 in use of a DPP-4 inhibitor other than anagliptin

LDL-cholesterol >= 120mg/dl
Key exclusion criteria HbA1c > 8%
LDL-cholesterol >= 160mg/dl
history of colonary disease
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiminori Hosoda
Organization Kyoto University Graduate School of Medicine
Division name Department of Health and Science
Zip code
Address Sakyo-ku, Kyoto
TEL 075-751-3172
Email kh@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Ebihara
Organization Kyoto University Hospital
Division name Institute for Advancement of Clinical and Translational Science
Zip code
Address Sakyo-ku, Kyoto
TEL 075075103173
Homepage URL
Email kebihara@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University
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

Other administrative information
Date of disclosure of the study information
2013 Year 12 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
2013 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 18 Day
Last modified on
2015 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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