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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Coronary Arterial Disease (CAD); Glucagon-Like Peptide-1 Receptor Agonists
• Intervention / Treatment: Drug: Semaglutide 1.0 mg; Drug: Semaglutide 0.5 mg

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chin-Sung Kuo, M.D., Ph.D.; Phone Number: +886-2-28757513; Email: cskuo@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
    • Contact: Chin-Sung Kuo, M.D., Ph.D.; Phone Number: +886-2-28757513; Email: cskuo@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: semaglutide 1.0mg weekly; continue previous standard treatment with add-on semaglutide	Drug: Semaglutide 1.0 mg; add-on current standard treatment which includes SGLT2 inhibitor
Active Comparator: semaglutide 0.5mg weekly; continue previous standard treatment with add-on semaglutide	Drug: Semaglutide 0.5 mg; add-on current standard treatment which includes SGLT2 inhibitor
No Intervention: control; continue previous standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of serum ROS measurements	serum ROS measurements at week 24 - serum ROS measurements at baseline	From enrollment to the end of treatment at 24 weeks
change of Peripheral Arterial Tonometry (PAT)	Peripheral Arterial Tonometry (PAT) at week 24 - Peripheral Arterial Tonometry (PAT) at baseline	From enrollment to the end of treatment at 24 weeks
Hypoglycemic episodes	the amount of hypoglycemic episodes during the treatment period of 24 weeks. hypoglycemic episodes defined as blood sugar levels less than 50 or with hypoglycemic symptoms.	from enrollment to the end of treatment at week 24.
change of fasting glucose	fasting glucose ar week 24 - fasting glucose at baseline	From enrollment to the end of treatment at week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of serum IL-1β	levels of serum IL-1β at week 24 - levels of serum IL-1β at baseline	From enrollment to the end of treatment at 24 weeks
change of serum IL-6	levels of serum IL-6 at week 24 - levels of serum IL-6 at baseline	From enrollment to the end of treatment at 24 weeks
change of serum IL-10	levels of serum IL-10 at week 24 - levels of serum IL-10 at baseline	From enrollment to the end of treatment at 24 weeks
change of serum TNF-α	levels of serum TNF-α at week 24 - levels of serum TNF-α at baseline	From enrollment to the end of treatment at 24 weeks
change of urinary 8-iso PGF 2alfa	urinary 8-iso PGF 2alfa at week 24 - urinary 8-iso PGF 2alfa at baseline	From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: June 16, 2025
• First Submitted That Met QC Criteria: July 9, 2025
• First Posted (Estimated): July 18, 2025

Study Record Updates

• Last Update Posted (Estimated): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: type 2 diabetes; coronary arterial disease; Glucagon-Like Peptide-1 Receptor Agonists
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Arteriosclerosis; Arterial Occlusive Diseases; Diabetes Mellitus, Type 2; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Semaglutide
• Other Study ID Numbers: 2025-02-004C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD share plan was not mentioned in this patient consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No