A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
- Status
- CompletedResults posted
- Who it enrolls
- age 18 Years to no upper limit; no BMI minimum stated; conditions: Diabetes Mellitus, Type 2
- Interventions
- Semaglutide; Placebo (semaglutide)
- Conditions
- Diabetes Mellitus, Type 2
- Phase and size
- Phase 3 · 3533 participants
- Dates
- Start 2019-06-17
Primary completion 2024-01-09 - Sponsor
- Novo Nordisk A/S (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV DeathFrom Week 0 up to Week 234
Published results in the collection
- Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 DiabetesRandomized trial · 2024 · Study tier 1 · Different population · Benefit · Industry funded
02Eligibility
Who can take part
Inclusion Criteria: * Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus * HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol) * Renal impairment defined either by: 1. 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) and UACR greater than 300 and less than 5000 mg/g or 2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g * Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) 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 the inclusion criteria for renal impairment and kept stable until screening Exclusion Criteria: * Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations * Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening * Presently classified as being in New York Heart Association (NYHA) Class IV heart failure * Planned coronary, carotid or peripheral artery revascularisation * Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
03Change log
Registry changes
No changes recorded since the trial was added.