UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008804 |
|---|---|
| Receipt number | R000009899 |
| Scientific Title | Influence of soluble CD26 to the improvement of blood glucose by Dipeptidyl peptidase-4 inhibitory drugs |
| Date of disclosure of the study information | 2012/08/30 |
| Last modified on | 2015/08/31 09:04:04 |
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Basic information
Public title
Influence of soluble CD26 to the improvement of blood glucose by Dipeptidyl peptidase-4 inhibitory drugs
Acronym
Influence of soluble CD26 to the improvement of blood glucose by Dipeptidyl peptidase-4 inhibitory drugs
Scientific Title
Influence of soluble CD26 to the improvement of blood glucose by Dipeptidyl peptidase-4 inhibitory drugs
Scientific Title:Acronym
Influence of soluble CD26 to the improvement of blood glucose by Dipeptidyl peptidase-4 inhibitory drugs
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
DPP-4/CD26 is known as novel adipokine.
We clarify the influence of soluble DPP-4/CD26 to the long-term blood gluose improvement by DPP-4 inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship betweenf blood glucose improvement by DPP-4 inhibitor and the consentration of serum CD26
Key secondary outcomes
Analysis of a correlation factor with Soluble CD26 concentration
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
sitagliptin 50mg/day, alogliptin 25mg/day
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
The person who meets the following standards in the outpatients with type 2 diabetes.
HbA1c(NGSP) of 7-10%
Key exclusion criteria
1. The patient who taking
thiazolidinedione
2. The patient who taking insulin, or
the absolute adaptation of insulin
therapy
3. The patient who has renal dysfunction
(Serum creatinine: male 1.5mg/dl<=,
female 1.3mg/dl<=)
4. The patient who has liver dysfunction
(ALT and AST: more than two times the
upper limit of normal)
5. The patient who has endocrine disease
6. The patient who taking steroid
7. The patient who has malignacy
8. The patient who has severe
psychiatric disease
9. The patient under pregnancy or
lactation
10. The excessive alcohol ingestion
11. The contraindication of the drugs
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Kaku |
Organization
Kawasaki medical school
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
577, Matsushima, Kurashiki-shi, Okayama-ken
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Shimoda |
Organization
Kawasaki medical school
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
577, Matsushima, Kurashiki-shi, Okayama-ken
TEL
086-462-1111
Homepage URL
Sponsor or person
Institute
Department of Diabetes, Endocrinology and Metabolism, Kawasaki medical scool
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
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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009899
| 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 |
