UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039095 |
|---|---|
| Receipt number | R000044536 |
| Scientific Title | The efficacy of Dulaglutide for the coronary plaque in patiENts with type 2 diabetes mellitus Evaluated By optical coherence tomography: single-center, randomized, open-label, parallel group study. |
| Date of disclosure of the study information | 2020/03/02 |
| Last modified on | 2022/07/14 16:41:16 |
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Basic information
Public title
The efficacy of Dulaglutide for the coronary plaque in patiENts with type 2 diabetes mellitus Evaluated By optical coherence tomography: single-center, randomized, open-label, parallel group study.
Acronym
DENEB study
Scientific Title
The efficacy of Dulaglutide for the coronary plaque in patiENts with type 2 diabetes mellitus Evaluated By optical coherence tomography: single-center, randomized, open-label, parallel group study.
Scientific Title:Acronym
DENEB study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the stabilizing effect of Dulaglutide on coronary plaque with standard treatment in patients with type 2 diabetes mellitus and coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of the Lipid Index calculated by OCT from baseline to treatment evaluation (week 38).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dulaglutide 0.75mg/week
Interventions/Control_2
Standard treatment without GLP-1 receptor agonist (GLP-1RA)
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 who underwent PCI for ACS, SAP or SMI.
(2)Patients who have not enough controlled type 2 diabetes mellitus (HbA1c(NGSP) over 7.0%).
(3)Patients who have moderate stenosis of 25-75% on non-culprit lesions and analyzable OCT images are obtained when PCI for the culprit lesion.
(4)Patients over 20 years of age at PCI.
(5)Patients who agree to be enrolled in the trial giving signed written informed consent.
Key exclusion criteria
(1)Type 1 diabetes mellitus.
(2)Hemodialysis patients
(3)Patients who have received one or more doses of glucagon-like peptide 1 receptor agonist.
(4)Patients with allergic drug hypersensitivity to drugs to be used.
(5)Patients who conflict with any of the warning contraindications listed.
(6)Pregnant women and pregnant or lactating patients.
(7)Familial hypercholesterolemia homozygote.
(8)Patients with a history of gastrointestinal injury, pancreatitis and ileus.
(9)Others Patients judged inappropriate by the doctor in charge of this exam.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Hospital
Division name
Cardiology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo-ken, Japan
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kakizaki |
Organization
Kobe University Hospital
Division name
Cardiology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo-ken, Japan
TEL
078-382-5846
Homepage URL
shun0114@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University, department of cardiology
Institute
Department
Personal name
Funding Source
Organization
none
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
Kobe University Hospital Intervention Research Ethics Review Board
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo-ken, Japan
Tel
078-382-6669
kainyu@med.kobe-u.ac.jp
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044536
