Can Semaglutide or empagliflozin stabilise coronary atherosclerosis in people with type 2 diabetes after acute coronary syndrome

Phase 2

• Conditions: Type 2 diabetes; Coronary atherosclerosis; Cardiovascular - Coronary heart disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12623000661673
• Lead Sponsor: South Australian Health and Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-19
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Hospitalisation with an acute coronary syndrome (as defined by the 2020 European Society of Cardiology (ESC) Guidelines for the Management of Acute Coronary Syndromes), where participant has undergone invasive coronary angiography and is left with residual atherosclerotic stenoses in one or more coronary arteries of at least 20% severity that will be left for medical management with no intention to revascularise by stenting or bypass grafting in the next 12 months
- Previous or new (in hospital) diagnosis of type 2 diabetes
- No contraindication to glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium glucose co-transporter-2 (SGLT2) inhibitor usage (see key exclusion criteria)
- Eligible to use either GLP-1 RA or SGLT2 inhibitor as per PBS criteria (in summary, patients must have type 2 diabetes, and be on treatment with metformin and/or sulfonylurea as tolerated, and have a HbA1c >7%)
- Willing to use injectable medication
- Willingness to be on birth control for women of childbearing age or established post-menopausal
- Participants are required to have undergone screening, enrolment, baseline imaging and randomisation and drug initiation within 30 days of their index admission for their acute coronary syndrome

Exclusion Criteria

- Contraindication to GLP-1 RA use, including history of pancreatitis (acute or chronic), and established retinopathy
- Contraindication to SGLT2 inhibitor use, including recurrent genitourinary infections, and history of ketoacidosis
- Known history of a clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction, or being planned for bariatric surgery within the next 12 months
- Left ventricular ejection fraction <=35% or New York Heart Association (NYHA) class IV heart failure
- A personal or family history of medullary thyroid carcinoma, or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2)
- Known type 1 diabetes
- Prior/known intolerance of GLP-1 receptor agonists or SGLT2 inhibitors
- Concurrent DPP4 use or use within the 2 weeks prior to randomisation occurring
- Dialysis or estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2
- Previous or planned coronary artery bypass grafting
- Pregnant women or women planning pregnancy in the following 12 months
- Life expectancy <1year
- Contraindications to CT coronary angiography
- Concurrent enrolment in another placebo-controlled trial or within 30 days of finishing another trial
- Enrolment and participation in another trial involving ionising radiation in the last 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression rates of low attenuation plaque under influence of GLP-1 RA as compared to SGLT2 inhibition as assessed by CT coronary angiography[Baseline and 12 months post-commencement of treatment]