A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

Key facts

Study ID

NCT03819153

Run by

Novo Nordisk A/S

People needed

3533

Starts

2019-06-17

Expected to finish

2024-01-09

Last updated by the study team

2025-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Inst Of Renal Res — Chula Vista, California, United States
• John Muir Physician Network — Concord, California, United States
• John Muir Physicians Network — Concord, California, United States
• Valley Research — Fresno, California, United States
• California Institute of Renal Research — La Mesa, California, United States
• First Valley Med Grp Lancaster — Lancaster, California, United States
• Clinical Trials Research_Sacramento — Lincoln, California, United States
• VA Loma Linda Hlthcr Sys — Loma Linda, California, United States
• Long Beach Center For Clinical Research — Long Beach, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Valley Renal Medical Group Research — Northridge, California, United States
• Desert Oasis Hlthcr Med Group — Palm Springs, California, United States
• Saviers Medical Group — Port Hueneme, California, United States
• Inland Empire Clin Trials LLC — Rialto, California, United States
• Sierra Clinical Research — Roseville, California, United States
• California Research Foundation — San Diego, California, United States
• N America Res Inst - San Dimas — San Dimas, California, United States
• NorCal Endocrinology and Internal Medicine — San Ramon, California, United States
• Lundquist Inst-Biomed Innovtn — Torrance, California, United States
• San Fernando Valley Hlth Inst — West Hills, California, United States
• Rocky Mount Reg VA Med-DN — Aurora, Colorado, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• BayCare Medical Group - Endocrinology — Clearwater, Florida, United States
• Dr. Terence Hart — Tuscumbia, Alabama, United States

Full record on ClinicalTrials.gov

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