UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019022 |
|---|---|
| Receipt number | R000021999 |
| Scientific Title | Efficacy of DPP-4 inhibitors for oxidative stress and inflammation in type 2 diabetic patients |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2015/09/15 01:08:44 |
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Basic information
Public title
Efficacy of DPP-4 inhibitors for oxidative stress and inflammation in type 2 diabetic patients
Acronym
Efficacy of DPP-4 inhibitors for oxidative stress and inflammation
Scientific Title
Efficacy of DPP-4 inhibitors for oxidative stress and inflammation in type 2 diabetic patients
Scientific Title:Acronym
Efficacy of DPP-4 inhibitors for oxidative stress and inflammation
Region
| Japan |
Condition
Condition
Type 2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of vildagliptin and alogliptin for glucose metabolism, oxidative stress, and anti-inflammatory effect
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of HbA1c at 12 and 24 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects who have not administered DPP-4 inhibitors were allocated randomly to either vildagliptin 100 mg/day or alogliptin 25 mg/day during 6 months.
Interventions/Control_2
Subjects who have not administered DPP-4 inhibitors were allocated randomly to either vildagliptin 100 mg/day or alogliptin 25 mg/day during 6 months.
Interventions/Control_3
Subjects who have administered sitagliptin 50 mg were allocated randomly to either vildagliptin 100 mg/day or alogliptin 25 mg/day during 6 months.
Interventions/Control_4
Subjects who have administered sitagliptin 50 mg were allocated randomly to either vildagliptin 100 mg/day or alogliptin 25 mg/day during 6 months.
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
1)Outpatients with type 2 diabetes who have not administered alogliptin or vildagliptin.
2)Subjects who give consent document about participation in the clinical study
Key exclusion criteria
(1) With diabetic ketoacidosis, diabetic coma and type 1 diabetes
(2) With severe infection
(3) Subjects who have administered insulin or glinide
(4) With severe liver dysfuction
(5) With severe kidney dysfunction
(6) Considered as inadequate by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Okada |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL
0936031611
y-okada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Tanaka |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL
0936031611
Homepage URL
kenichi.tanaka0801@gmail.com
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
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
| 2015 | Year | 09 | Month | 15 | 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 | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 31 | 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
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2015 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021999
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
