UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023463 |
|---|---|
| Receipt number | R000027009 |
| Scientific Title | Effect of alogliptin/pioglitazone on endothelial function and Visceral fat of Type 2Diabetes |
| Date of disclosure of the study information | 2016/08/03 |
| Last modified on | 2018/03/12 08:54:47 |
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Basic information
Public title
Effect of alogliptin/pioglitazone on endothelial function and Visceral fat of Type 2Diabetes
Acronym
Effect of alogliptin/pioglitazone on endothelial function and Visceral fat of Type 2Diabetes
Scientific Title
Effect of alogliptin/pioglitazone on endothelial function and Visceral fat of Type 2Diabetes
Scientific Title:Acronym
Effect of alogliptin/pioglitazone on endothelial function and Visceral fat of Type 2Diabetes
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of pioglitazone or sulfonylurea on endothelial function and Visceral fat of Type 2 diabetes who treated alogliptin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endothelial function after 6 months on pioglitazone
or sulfonylurea
Key secondary outcomes
The change of body weight,blood pressure,visceral fat
HbA1c,blood glucose,LDL,HDL,non HDL,adiponectin,and
8epiPGF2A after 6 months treatment of pioglitazone or sulfonylurea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pioglitazone15mg 6months
Interventions/Control_2
sulfonylurea 6months
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
Type2 diabetes treated with alogliptin
(including treated another antidiabetic drugs and insulin )
Key exclusion criteria
1)Patients with hypersensitivity to the components of alogliptin or sulfonylurea.
2)Patients with severe ketosis ,diabetic coma or pre coma.
3)Patients with severe infection,before and after surgery,severe trauma.
4)Patient with advanced renal dysfunction(eGFR<30) or patient on dialysis.
5)Patients with severe liver dysfunction.
6)Patients with pregnancy or possibility.
7)Patients whom physician in charge considered inappropriate for study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Aso |
Organization
Dokkyo medical university hospital
Division name
Endocrinology and Metabolism
Zip code
Address
880,Kitakobayashi,Mibu,Shimotsugagun,Tochigi
TEL
0282-86-1111
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Aoki |
Organization
Dokkyo medical university hospital
Division name
Endocrinology and Metabolism
Zip code
Address
880,Kitakobayashi,Mibu,Shimotsugagun,Tochigi
TEL
0282-86-1111
Homepage URL
c-aoki@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo medical university hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 03 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027009
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
