UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011862 |
|---|---|
| Receipt number | R000013865 |
| Scientific Title | Examination of the usefulness of DPP-4 inhibitor in the treatment of type 2 diabetes |
| Date of disclosure of the study information | 2013/10/02 |
| Last modified on | 2014/03/25 13:00:07 |
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Basic information
Public title
Examination of the usefulness of DPP-4 inhibitor in the treatment of type 2 diabetes
Acronym
Examination of the usefulness of DPP-4 inhibitor in the treatment of type 2 diabetes
Scientific Title
Examination of the usefulness of DPP-4 inhibitor in the treatment of type 2 diabetes
Scientific Title:Acronym
Examination of the usefulness of DPP-4 inhibitor in the treatment of type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of the usefulness of selective DPP-4 inhibitor Vildagliptin for patients with type 2 diabetes who is inadequate glycemic controll by sitaguliptin(50mg/day).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Surrogate marker(inflammation and oxidative stress)
Continuous Glucose Monitoring
Key secondary outcomes
HbA1c
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
Vildagliptin
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
1)Patients with type 2 diabetes inadequately controlled with sitaguliptin
HbA1c(NGSP) of >= 7.0%
2)Patients with type 2 diabetes treated by diet and exercise therapy
3)Given informed consent
Key exclusion criteria
1)Under insulin treatment (diabetic ketoacidosis , diabetic coma , type 1 diabetes , etc)
2)Has allergy to vildagliptin
3)Severe liver dammge
4)After severe infection,operation or injury
5)Patient who was considered to be appropriate to this study by attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Naka Kinen Clinic
Division name
Director
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki,311-0113,Japan
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ofuchi |
Organization
Naka Kinen Clinic
Division name
Clinical Laboratory
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki,311-0113,Japan
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Naka Kinen Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Life and Environmental Sciences,University of Yamanashi
Name of secondary funder(s)
None
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
那珂記念クリニック(茨城県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 02 | 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 | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 25 | Day |
Last modified on
| 2014 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013865
