Status:
COMPLETED
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active me...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- 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
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
3533 Patients enrolled
Trial Details
Trial ID
NCT03819153
Start Date
June 17 2019
End Date
January 9 2024
Last Update
March 20 2025
Active Locations (413)
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1
Dr. Terence Hart
Tuscumbia, Alabama, United States, 35674
2
California Inst Of Renal Res
Chula Vista, California, United States, 91910
3
John Muir Physician Network
Concord, California, United States, 94520
4
John Muir Physicians Network
Concord, California, United States, 94520