UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011470 |
|---|---|
| Receipt number | 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 09:14:22 |
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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
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
Sponsor or person
Institute
Nara Hospital Kinki University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013425
