The Role of Glucagon-Like Peptide-1 Receptor Agonists in Coronary Artery Diseases and Their Potential Mechanisms

NCT07073053 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-02-004C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to enroll 60 patients from the outpatient clinics or inpatient wards of the Metabolism and Cardiology departments who, within the past three months, have undergone coronary angiography for the treatment of coronary artery disease, are currently using sodium-glucose cotransporter-2 (SGLT-2) inhibitors for glycemic control, and have not received glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy for more than three months. A randomized controlled clinical trial will be conducted, with 20 participants randomly assigned to receive semaglutide (a GLP-1 RA) at 1 mg once weekly for 6 months, another 20 participants to receive semaglutide at 0.5 mg once weekly for 6 months, and the control group (20 participants) to continue with standard treatment for 6 months. The effects after 6 months will be evaluated in terms of endothelial function, glycemic control indicators including glycemic variability assessed via continuous glucose monitoring (CGM), oxidative stress markers, and the incidence of symptomatic hypoglycemia. According to the treatment guidelines for type 2 diabetes, either GLP-1 receptor agonists or SGLT-2 inhibitors should be prioritized in patients with type 2 diabetes and coronary artery disease. Therefore, the medication choices in both the intervention and control groups in this study align with current treatment guidelines.

Conditions

Glucagon-Like Peptide-1 Receptor Agonists; Type 2 Diabetes; Coronary Arterial Disease (CAD)

Keywords

Glucagon-Like Peptide-1 Receptor Agonists; type 2 diabetes; coronary arterial disease

Outcome Measures

Primary Outcomes (3)

• change of Time-in-range (%)

  continuous glucose monitor, time-in-range defined as percentage of time in range of 70-180 blood glucose levels. Change of time-in-range means time-in-range at week 24 - time-in-range at baseline.

  From enrollment to the end of treatment at 24 weeks

• change of HbA1c

  HbA1c at week 24 - HbA1c at baseline

  From enrollment to the end of treatment at 24 weeks

• change of Flow-Mediated Dilatation (FMD)

  Flow-Mediated Dilatation (FMD) at week 24 - Flow-Mediated Dilatation (FMD) at baseline

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (4)

• change of serum ROS measurements

  From enrollment to the end of treatment at 24 weeks

• change of Peripheral Arterial Tonometry (PAT)

  From enrollment to the end of treatment at 24 weeks

• Hypoglycemic episodes

  from enrollment to the end of treatment at week 24.

• change of fasting glucose

  From enrollment to the end of treatment at week 24

Other Outcomes (5)

• change of serum IL-1β

  From enrollment to the end of treatment at 24 weeks

• change of serum IL-6

  From enrollment to the end of treatment at 24 weeks

• change of serum IL-10

  From enrollment to the end of treatment at 24 weeks

Study Arms (3)

semaglutide 1.0mg weekly

EXPERIMENTAL

continue previous standard treatment with add-on semaglutide

Drug: Semaglutide 1.0 mg

semaglutide 0.5mg weekly

ACTIVE COMPARATOR

continue previous standard treatment with add-on semaglutide

Drug: Semaglutide 0.5 mg

control

NO INTERVENTION

continue previous standard treatment

Interventions

Semaglutide 1.0 mg DRUG

add-on current standard treatment which includes SGLT2 inhibitor

semaglutide 1.0mg weekly

Semaglutide 0.5 mg DRUG

add-on current standard treatment which includes SGLT2 inhibitor

semaglutide 0.5mg weekly

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (\>=20 years old),
• Type 2 Diabetes with coronary arterial disease underwent angioplasty within 3 months with SGLT2 inhibitors -

You may not qualify if:

• age\<20 years old,
• pregnant women,
• eGFR\<30 ml/min/1.73m2,
• received GLP-1 agonist in the recent 3 months -

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Chin-Sung Kuo, M.D., Ph.D.

CONTACT

+886-2-28757513; cskuo@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)