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Clinical Trial NCT07073053 for Glucagon-Like Peptide-1 Receptor Agonists, Type 2 Diabetes, Coronary Arterial Disease (CAD) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Role of Glucagon-Like Peptide-1 Receptor Agonists in Coronary Artery Diseases and Their Potential Mechanisms Phase 4 60 Randomized
Clinical Trial NCT07073053 is designed to study Treatment for Glucagon-Like Peptide-1 Receptor Agonists, Type 2 Diabetes, Coronary Arterial Disease (CAD). This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on October 1, 2025 until the study accrues 60 participants. Led by Taipei Veterans General Hospital, Taiwan, this study is expected to complete by July 31, 2028. The latest data from ClinicalTrials.gov was last updated on July 18, 2025.
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)...Show More
Official Title
The Role of Glucagon-Like Peptide-1 Receptor Agonists in Coronary Artery Diseases and Their Potential Mechanisms
Conditions
Glucagon-Like Peptide-1 Receptor AgonistsType 2 DiabetesCoronary Arterial Disease (CAD)Other Study IDs
- 2025-02-004C
NCT ID Number
Start Date (Actual)
2025-10-01
Last Update Posted
2025-07-18
Completion Date (Estimated)
2028-07-31
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Glucagon-Like Peptide-1 Receptor Agonists
type 2 diabetes
coronary arterial disease
type 2 diabetes
coronary arterial disease
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalsemaglutide 1.0mg weekly continue previous standard treatment with add-on semaglutide | Semaglutide 1.0 mg add-on current standard treatment which includes SGLT2 inhibitor |
Active Comparatorsemaglutide 0.5mg weekly continue previous standard treatment with add-on semaglutide | Semaglutide 0.5 mg add-on current standard treatment which includes SGLT2 inhibitor |
No Interventioncontrol continue previous standard treatment | N/A |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
All
- adults (>=20 years old),
- Type 2 Diabetes with coronary arterial disease underwent angioplasty within 3 months with SGLT2 inhibitors -
- age<20 years old,
- pregnant women,
- eGFR<30 ml/min/1.73m2,
- received GLP-1 agonist in the recent 3 months -
Taipei Veterans General Hospital, TaiwanStudy Central Contact
Contact: Chin-Sung Kuo, M.D., Ph.D., +886-2-28757513, [email protected]
1 Study Locations in 1 Countries
Taipei Veterans General Hospital, Taipei, 112, Taiwan
Chin-Sung Kuo, M.D., Ph.D., Contact, +886-2-28757513, [email protected]