DAPAGLIFLOZIN for Coronary artery disease|Prediabetes

Inclusion criteria

• {"criterion_text":"- Chronic coronary syndrome with documented coronary artery disease. In the case of previous myocardial infarction, at least 30 days between the event and randomization is required.\n- Prediabetes defined as HbA1c 42-47 mmol/mol OR normoglycemia defined as HbA1c <39 mmol/mol\n- Age 18 to 80 years"}

Exclusion criteria

• {"criterion_text":"- eGFR <30 mL/min/1.73 m2\n- Heart failure with NYHA class III or IV\n- Previous diabetes diagnosis, previous HbA1c >47 mmol/mol, or current/previous usage of diabetes medication\n- Anemia, recent bleeding or blood transfusion (<3 months)\n- Previous pancreatitis\n- Pregnancy, breastfeeding, or fertile women who do not use highly effective birth control\n- Strongly reduced liver function\n- Chronic alcohol abuse\n- Known hemoglobinopathy and other conditions with effect on erythrocyte lifespan\n- Intake of medications with known effect on HbA1c validity"}

Primary endpoints

• {"endpoint_text":"- Presence of a composite of retinopathy, nephropathy, neuropathy, and MASLD in patients with chronic coronary syndrome and prediabetes versus normoglycemia.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of normoglycemia defined as HbA1c <39 mmol/mol after 1 year in the interventional therapy arm compared with conventional therapy.","definition_or_measurement_approach":"Defined as HbA1c <39 mmol/mol at 1 year; comparison between interventional therapy arm and conventional therapy."}

Secondary endpoints

• {"endpoint_text":"- To examine the 2-year incidence of recurrence of prediabetes or progression to type 2 diabetes in patients with chronic coronary syndrome and initial prediabetes treated with glucose-lowering medications for one year compared with conventional therapy.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Baseline presence of a composite of retinopathy, nephropathy, and neuropathy in patients with chronic coronary syndrome and prediabetes versus normoglycemia..","definition_or_measurement_approach":""}
• {"endpoint_text":"- Baseline presence of retinopathy, nephropathy, neuropathy or MASLD, respectively, in patients with chronic coronary syndrome and prediabetes versus normoglycemia.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 1-year incidence of normoglycemia defined as HbA1c <42 mmol/mol","definition_or_measurement_approach":"Defined as HbA1c <42 mmol/mol at 1 year."}
• {"endpoint_text":"- Change in HbA1c","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in eGFR","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in cystatin-C","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in hs-CRP","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in lipid parameters","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in c-peptide","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in HOMA-IR","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in Fib-4","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in CD163","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in PRO-C3","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in MASLD severity","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in urine albumin-creatinine ratio","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in weight","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in waist circumference","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2-year incidence of type 2 diabetes in the interventional therapy arm compared with conventional therapy.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Prevalence of prediabetes defined as HbA1c 42-47 mmol/mol in the interventional therapy arm compared with conventional therapy.","definition_or_measurement_approach":"Prediabetes definition specified as HbA1c 42-47 mmol/mol."}
• {"endpoint_text":"- Prevalence of prediabetes defined as HbA1c 39-47 mmol/mol in the interventional therapy arm compared with conventional therapy.","definition_or_measurement_approach":"Prediabetes definition specified as HbA1c 39-47 mmol/mol."}

Denmark

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

23-11-2025

Processing Time Days

16

Number Of Sites

1

Number Of Participants

158

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: 1;8","organisation_type":"Educational Institution"}