Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT05457933
Eligibility Criteria:
Inclusion Criteria:
1. Males or females 30 years or above admitted to the hospital for elective CABG surgery
2. A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy.
3. Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 12 units per day.
4. Signed, informed consent prior to any study procedures
Exclusion Criteria:
1. Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia).
2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c \<7%.
3. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
4. Patients treated with long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).
5. Any known hypersensitivity to dapagliflozin.
6. History of recurrent urinary tract infections (\>2 episodes) requiring antibiotic therapy in the last 1 year.
7. History of intolerance to dapagliflozin or any other sodium-glucose cotransporter 2 inhibitors.
8. Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension).
9. Patients with ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day).
10. Patients with impaired renal function (eGFR \<45 ml/min/1.73m2).
11. Patients with congestive heart failure (NYHA- IV).
12. Patients with medical and surgical pancreatic disease.
13. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
14. Body mass index (BMI) \<18.5 kg/m2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT05457933
Study Brief:
Protocol Section:
NCT05457933