Phase 3Completed

A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)

Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease

Sponsor
Novo Nordisk A/S (Industry)
Enrolment
106 enrolled
Conditions
Diabetes Mellitus, Type 2; Chronic Kidney Disease
Interventions
Semaglutide; Placebo (Semaglutide)
Ages
adults, older adults
Registry
NCT04865770

From the registry

We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys. Participants will either get semaglutide or placebo (a 'dummy' 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 into the skin once a week. The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations. Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours. The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a…

Primary outcomes

  • Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*)
  • Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)
  • Change in Global Kidney Perfusion (MRI)
  • Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)
Full record on ClinicalTrials.gov

Papers citing this trial

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