FLOW: semaglutide and kidney outcomes in type 2 diabetes with chronic kidney disease

A large trial of people who have both type 2 diabetes and chronic kidney disease. Half took semaglutide 1.0 mg once a week and half took placebo. The semaglutide group had a lower risk of kidney failure, a large fall in kidney function, or death from a kidney or heart cause. The trial was stopped early at a planned interim check.

Also called FLOW

  • Study
  • In this atlas

Overview

Design
Randomized, placebo-controlled trial with parallel groups. The registry records phase 3 and quadruple masking.
Phase
Phase 3
Enrolled
  • 3,533 participants (enrolled count) (A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03819153
Started
(actual) (A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease, retrieved )
Primary completion
(actual) (A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease, retrieved )
Completion
(actual) (A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease, retrieved )
Results first posted
(actual) (A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease, retrieved )
Countries
United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Russia, Slovakia, South Africa, Spain, Thailand, Ukraine, United Kingdom, Türkiye (A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )
Stopped early
The trial stopped early, date not reported. Early cessation of the trial was recommended at a prespecified interim analysis. The sentence read does not give the reason. The registry records the study as completed. (Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes, retrieved )

Technical summary

Randomized, placebo-controlled trial sponsored by Novo Nordisk (NCT03819153). 3533 participants were randomized (1767 semaglutide, 1766 placebo), median follow-up 3.4 years. Primary outcome (kidney failure, at least a 50% reduction in eGFR, or death from kidney-related or cardiovascular causes): 331 against 410 first events, hazard ratio 0.76 (95% CI 0.66 to 0.88; P=0.0003). Early cessation was recommended at a prespecified interim analysis.

Arms

  • Semaglutide

    Intervention Semaglutide

    Subcutaneous semaglutide 1.0 mg once weekly, added to standard care.

  • Placebo

    Intervention None named

    Placebo, added to standard care.

Findings

No findings are published for this study.

Record details

Record id
cardio:flow-trial
Content hash
2d60ed3f20a3b94727232ab307f264121ec2487b414c0f2097dcecbe2bdf3f91