A Research Study Looking at Kidney and Heart Health in Adults With Type 2 Diabetes and Chronic Kidney Disease Treated With Semaglutide in China

Korábbi kezelés

• Use of any glucagon-like peptide-1 receptor agonist (GLP1 RA) within 30 days prior to screening. This also includes dual agonists containing a GLP1 RA component.
• Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination and optical coherence tomography performed within the past 90 days prior to screening or in the period between screening and enrolment. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.
• Combination use of an angiotensin-converting enzyme inhibitor and an angiotensin-II receptor blocker (ARB).

Más betegség

• Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.

Egyéb

• Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis.

• Age 18 years or above at the time of signing the informed consent
• Diagnosed with type 2 diabetes (T2D)
• HbA1c less than or equal to (≤) 10 % (≤ 86 millimoles per mole [mmol/mol])
• Kidney impairment defined either by:
  • serum creatinine-based eGFR greater than or equal to (≥) 50 and less than or equal to (≤) 75 mL/min/1.73 m\^2 (CKD-EPI, 2009) and UACR greater than (>) 300 and less than (<) 5000 milligrams per gram (mg/g) or
  • serum creatinine-based eGFR ≥ 25 and < 50 mL/min/1.73 m\^2 (CKD-EPI, 2009) and UACR > 100 and < 5000 mg/g
• Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of inclusion criterion and kept stable until screening.
  • Laboratory results for inclusion can be based on:
• measurements no more than 90 days old at screening, documented in medical records or
• central laboratory measurement obtained at the screening visit If using UACR and eGFR values from medical records for inclusion, these values must be entered in the electronic case report form.
  • The number of participants with inclusion eGFR ≥ 60 mL/min/1.73 m\^2 will be capped at 20% of enrolled participants.