UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046686 |
|---|---|
| Receipt number | R000053215 |
| Scientific Title | The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes |
| Date of disclosure of the study information | 2022/01/21 |
| Last modified on | 2022/01/20 10:41:17 |
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Basic information
Public title
The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Acronym
The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Scientific Title
The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Scientific Title:Acronym
The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of DPP4 inhibitor on peripheral insulin resistance by the glucose clamp technique and on postprandial glucose metabolism by the meal tolerance test in Japanese patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of glucose infusion rate during euglycemic-hyperinsulinemic clamp and improvement of HbA1c and postprandial blood glucose.
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
DPP4 inihibitor
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
type 2 diabetes mellitus patient.
Key exclusion criteria
Type 1 diabetes mellitus, pancreatic disease, liver disease, renal failure, or those taking diabetogenic medications such as corticosteroids
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okura |
Organization
Tottori University Faculty of Medicine
Division name
Endocrinology and Metabolism
Zip code
683-8504
Address
36-1 Nisi-Cho, Yonago
TEL
0859386517
ohkura@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okura |
Organization
Tottori University Faculty of Medicine
Division name
Endocrinology and Metabolism
Zip code
683-8504
Address
36-1 Nisi-Cho, Yonago
TEL
0859386517
Homepage URL
ohkura@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tottori University Faculty of Medicine
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
Tottori University Faculty of Medicine
Address
36-1 Nisi-Cho, Yonago
Tel
0859386517
ohkura@tottori-u.ac.jp
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
| 2022 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/tonyobyo/59/1/59_59/_pdf/-char/ja
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/tonyobyo/59/1/59_59/_pdf/-char/ja
Number of participants that the trial has enrolled
10
Results
improved insulin resistance
Results date posted
| 2022 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
type 2 DM
Participant flow
outpatients
Adverse events
none
Outcome measures
GIR
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053215
| 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 |
