Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07073053

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Semaglutide 1.0 mg

Drug

add-on current standard treatment which includes SGLT2 inhibitor

Semaglutide 0.5 mg

Drug

add-on current standard treatment which includes SGLT2 inhibitor

Primary outcomes

  1. change of Time-in-range (%)

    Time frame: From enrollment to the end of treatment at 24 weeks

    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.

  2. change of HbA1c

    Time frame: From enrollment to the end of treatment at 24 weeks

    HbA1c at week 24 - HbA1c at baseline

  3. change of Flow-Mediated Dilatation (FMD)

    Time frame: From enrollment to the end of treatment at 24 weeks

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

Secondary outcomes

  1. change of serum ROS measurements

    Time frame: From enrollment to the end of treatment at 24 weeks

    serum ROS measurements at week 24 - serum ROS measurements at baseline

  2. change of Peripheral Arterial Tonometry (PAT)

    Time frame: From enrollment to the end of treatment at 24 weeks

    Peripheral Arterial Tonometry (PAT) at week 24 - Peripheral Arterial Tonometry (PAT) at baseline

  3. Hypoglycemic episodes

    Time frame: from enrollment to the end of treatment at week 24.

    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.

  4. change of fasting glucose

    Time frame: From enrollment to the end of treatment at week 24

    fasting glucose ar week 24 - fasting glucose at baseline

Other outcomes

  1. change of serum IL-1β

    Time frame: From enrollment to the end of treatment at 24 weeks

    levels of serum IL-1β at week 24 - levels of serum IL-1β at baseline

  2. change of serum IL-6

    Time frame: From enrollment to the end of treatment at 24 weeks

    levels of serum IL-6 at week 24 - levels of serum IL-6 at baseline

  3. change of serum IL-10

    Time frame: From enrollment to the end of treatment at 24 weeks

    levels of serum IL-10 at week 24 - levels of serum IL-10 at baseline

  4. change of serum TNF-α

    Time frame: From enrollment to the end of treatment at 24 weeks

    levels of serum TNF-α at week 24 - levels of serum TNF-α at baseline

  5. change of urinary 8-iso PGF 2alfa

    Time frame: From enrollment to the end of treatment at 24 weeks

    urinary 8-iso PGF 2alfa at week 24 - urinary 8-iso PGF 2alfa at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+886-2-28757513

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.