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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011470
Receipt No. R000013425
Scientific Title Effect of alogliptin , a DPP-4 inhibitor, on markers of lipid metabolism in type 2 diabetic patients
Date of disclosure of the study information 2013/08/13
Last modified on 2013/08/13

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Basic information
Public title Effect of alogliptin , a DPP-4 inhibitor, on markers of lipid metabolism in type 2 diabetic patients
Acronym Effect of alogliptin , a DPP-4 inhibitor, on markers of lipid metabolism in type 2 diabetic patients
Scientific Title Effect of alogliptin , a DPP-4 inhibitor, on markers of lipid metabolism in type 2 diabetic patients
Scientific Title:Acronym Effect of alogliptin , a DPP-4 inhibitor, on markers of lipid metabolism in type 2 diabetic patients
Region
Japan

Condition
Condition type 2 diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using the DPP-4 inhibitor alogliptin, we focused on Apo B and Apo A-1, in addition to lipid metabolism markers, and investigated the effect of alogliptin on markers predicting cardiovascular events, such as Apo B/Apo A-1 and LDL/Apo B.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change of Apo protein,Apo B Apo-A1,after 8 weeks
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 alogliptin 25 mg/day was administered for eight weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria taking oral hypoglycemic agents and had HbA1c levels of 6.9% or higher for three months or longer.
Key exclusion criteria patients receiving insulin therapy; severe liver or renal dysfunction; patients with hypersensitivity to alogliptin; patients that had their hypoglycemic agents changed within three months; pregnant women or breast-feeding mothers; and excessive alcohol drinkers.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuzuru Kishitani
Organization Nara Hospital Kinki University Faculty of Medicine
Division name Gastroenterology, Endocrinology
Zip code
Address 1248-1 otoda town,ikoma city,NARA
TEL 0743-77-0880
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuzuru Kishitani
Organization Nara Hospital Kinki University Faculty of Medicine
Division name Gastroenterology, Endocrinology
Zip code
Address 1248-1 otoda town,ikoma city,NARA
TEL
Homepage URL
Email

Sponsor
Institute Nara Hospital Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 近畿大学医学部奈良病院(奈良県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 13 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
The presentation at the 55th Japan Diabetes Society Annual Scientific Meeting
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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 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

Management information
Registered date
2013 Year 08 Month 13 Day
Last modified on
2013 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013425

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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