UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011071 |
|---|---|
| Receipt number | R000012960 |
| Scientific Title | Clinical efficacy of anagliptin administration in type 2 diabetic patients |
| Date of disclosure of the study information | 2013/06/29 |
| Last modified on | 2013/06/29 01:08:59 |
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Basic information
Public title
Clinical efficacy of anagliptin administration in type 2 diabetic patients
Acronym
Clinical efficacy of anagliptin administration in type 2 diabetic patients
Scientific Title
Clinical efficacy of anagliptin administration in type 2 diabetic patients
Scientific Title:Acronym
Clinical efficacy of anagliptin administration in type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of anagliptin on glycemic control,fat,renal function and heart function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Glycemic control,fat,renal function and heart function after treatment with anagliptin.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Newly-diagnosed type 2 diabetic patients with inadequate glycemic control on diet and exercise
Type 2 diabetic patients being treated with oral hypoglycemic agent,whose differences of HbA1c(measured continuously at intervals of one month or more) are less than 0.5%
1)HbA1c:more than 6.0% less than 10.0%
2)Age:more than 20 years(at the time of informed consent date)
3)No restriction on gender
4)Ability to provide written informed consent for this study
Key exclusion criteria
Out of above criteria
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Setsuya Okubo |
Organization
Kuwana East Medical Center
Division name
Cardiology
Zip code
Address
3-11 Kotobuki Kuwana,Mie,Japan
TEL
0594-22-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Setsuya Okubo |
Organization
Kuwana East Medical Center
Division name
Department of Cardiology
Zip code
Address
3-11 Kotobuki Kuwana,Mie,Japan
TEL
0594-22-1211
Homepage URL
Sponsor or person
Institute
Kuwana East Medical Center Cardiology
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have expected that there are the same Clinical Effect of anagliptin compared with Other DPP4-inhibitor agent.
Management information
Registered date
| 2013 | Year | 06 | Month | 29 | Day |
Last modified on
| 2013 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012960
