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
- Sponsor
- Funder
- Not recorded
- Registry
-
NCT03819153
-
- Started
- (actual)
- Primary completion
- (actual)
- Completion
- (actual)
- Results first posted
- (actual)
- 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
- Care setting
- Not reported
- Registry status
- “COMPLETED”
- 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.
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
Placebo, added to standard care.
Findings
No findings are published for this study.
Record details
- Record id
cardio:flow-trial- Content hash
2d60ed3f20a3b94727232ab307f264121ec2487b414c0f2097dcecbe2bdf3f91