FLOW
Trial question
What is the effect of semaglutide in patients with T2DM and CKD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 3533
3533 patients (1069 female, 2464 male).
Inclusion criteria: patients with T2DM and CKD.
Key exclusion criteria: congenital or hereditary kidney disease; use of GLP-1 receptor agonists within 30 days before screening; NYHA Class IV HF; planned coronary, carotid, or peripheral artery revascularization; current chronic or intermittent hemodialysis or peritoneal dialysis.
Interventions
N=1767 semaglutide (at a subcutaneous dose of 0.25 mg once weekly for 4 weeks, then 0.5 mg once weekly for another 4 weeks, followed by a maintenance dose of 1.0 mg once weekly).
N=1766 placebo (matching placebo for 8 weeks).
Primary outcome
Major kidney disease events
18.7%
23.2%
23.2 %
17.4 %
11.6 %
5.8 %
0.0 %
Semaglutide
Placebo
Significant
decrease ▼
NNT = 22
Significant decrease in major kidney disease events (18.7% vs. 23.2%; HR 0.76, 95% CI 0.66 to 0.88).
Secondary outcomes
Significant decrease in mean annual rate of decline in eGFR (2.19 mL/min/1.73 m² vs. 3.36 mL/min/1.73 m²; MD -1.16, 95% CI -1.47 to -0.86).
Significant decrease in major CV events (12% vs. 14.4%; HR 0.82, 95% CI 0.68 to 0.98).
Significant decrease in death from any cause (12.8% vs. 15.8%; HR 0.8, 95% CI 0.67 to 0.95).
Safety outcomes
No significant differences in allergic reactions, hepatic disorder, or severe hypoglycemia.
Significant difference in serious adverse events (49.6% vs. 53.8%).
Conclusion
In patients with T2DM and CKD, semaglutide was superior to placebo with respect to major kidney disease events.
Reference
Vlado Perkovic, Katherine R Tuttle, Peter Rossing et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024 Jul 11;391(2):109-121.
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