UMIN-CTR Clinical Trial

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
Email	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
Email	shun0114@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University, department of cardiology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044536