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.

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. - DENEB study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039095

Enrollment

Registered

2020-03-02

Start date

2020-03-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Dulaglutide 0.75mg/week Standard treatment without GLP-1 receptor agonist (GLP-1RA)

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The change of the Lipid Index calculated by OCT from baseline to treatment evaluation (week 38).	—

Countries

Japan

Contacts

Public ContactShunsuke Kakizaki

Kobe University Hospital Cardiology

shun0114@med.kobe-u.ac.jp078-382-5846

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026