UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027913 |
|---|---|
| Receipt number | R000031384 |
| Scientific Title | Study of improvement effect by switching to duraglutide or addition of empagliflozin to patients mith poor blood glucose control under multidrug combination including dipeptidyl peptidase-4inhibitor(Randomized openlabel comparative clinical study) |
| Date of disclosure of the study information | 2017/06/25 |
| Last modified on | 2017/06/24 13:48:09 |
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Basic information
Public title
Study of improvement effect by switching to duraglutide or addition of empagliflozin to patients mith poor blood glucose control under multidrug combination including dipeptidyl peptidase-4inhibitor(Randomized openlabel comparative clinical study)
Acronym
Study of improvement effect by switching to duraglutide or addition of empagliflozin to patients mith poor blood glucose control under multidrug combination including dipeptidyl peptidase-4inhibitor(Randomized openlabel comparative clinical study)
Scientific Title
Study of improvement effect by switching to duraglutide or addition of empagliflozin to patients mith poor blood glucose control under multidrug combination including dipeptidyl peptidase-4inhibitor(Randomized openlabel comparative clinical study)
Scientific Title:Acronym
Study of improvement effect by switching to duraglutide or addition of empagliflozin to patients mith poor blood glucose control under multidrug combination including dipeptidyl peptidase-4inhibitor(Randomized openlabel comparative clinical study)
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Object is establish a guide to duraglutide and empagliflozin to patients mith poor blood glucose control under multidrug combination including dipepeptidyl peptidase-4 inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c(16 weeks later)
Key secondary outcomes
glucose,hypoglycemia frequency,LDL-cholesterol,triglyceride,AST,ALT,BUN,creatinine,hyper tension
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
change to GLP1receptor agonist
(dulaglutide 0.75mg s.c.)
Interventions/Control_2
add on SGLT2inhibitor
(empagliflozin 10mg p.o.)
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
| 21 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetes treat with dpp4inhibitor
Key exclusion criteria
over 65 age
insulin user
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawasumi Masahiko |
Organization
Juntendo university Nerima hospital
Division name
diabetes
Zip code
Address
3-1-10 takanodai,Nerima-ku,Tokyo 177-8521,Japan
TEL
03-5923-3240
kawasumi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwashita Ayako |
Organization
Juntendo university hospital
Division name
diabetes
Zip code
Address
3-1-3 hongou,bunkyo-ku,Tokyo 113-8431,Japan
TEL
03-3813-3111
Homepage URL
kawasumi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university Nerima hospital
diabetes
Institute
Department
Personal name
Funding Source
Organization
Juntendo university Nerima hospital
diabetes
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 24 | Day |
Last modified on
| 2017 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031384
