UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023394 |
|---|---|
| Receipt number | R000026955 |
| Scientific Title | Match-up of two once weekly GLP-1 receptor agonists (exenatide,dulaglutide) about efficacy and satisfaction |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/01/16 09:43:29 |
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Basic information
Public title
Match-up of two once weekly GLP-1 receptor agonists (exenatide,dulaglutide) about efficacy and satisfaction
Acronym
Match-up of two once weekly GLP-1 receptor agonists
Scientific Title
Match-up of two once weekly GLP-1 receptor agonists (exenatide,dulaglutide) about efficacy and satisfaction
Scientific Title:Acronym
Match-up of two once weekly GLP-1 receptor agonists
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare once weekly GLP-1 receptor agonists about efficacy of glucose lowering, weight reduction and satisfaction with treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction with treatment
(12weeks after treatment)
Key secondary outcomes
HbA1c
body weight
(12weeks after treatment)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
once weekly exenatide(12 weeks)
Interventions/Control_2
once weekly dulaglutide(12 weeks)
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
outpatient
age lower limit 20, upper limit 80
HbA1c over 7.0%
eGFR over 60
outpatients who agreed to join in our study
Key exclusion criteria
contraindication of GLP-1 receptor agonist
taking DPP4-inhibitor
using other GLP-1 receptor agonist
possibility of precnancy
influence of evaluation of intervention drugs
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Odawara |
Organization
Tokyo Medical University
Division name
Diabetology, Metabolism, and Endocrinology
Zip code
Address
6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL
+81-3-3342-6111
odawara@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junpei Shikuma |
Organization
Tokyo Medical University
Division name
Diabetology, Metabolism, and Endocrinology
Zip code
Address
6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL
+81-3-3342-6111
Homepage URL
inugumitoui@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
| 2016 | Year | 08 | Month | 01 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026955
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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