Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes
- Design
- Randomized trial · 3533 participants · Hard outcome
- Match to healthy normal-weight adults aged 55–75
- Different populationEvery participant had type 2 diabetes and albuminuric CKD. No inference to people with normal kidney function and no diabetes.
- Could weight loss explain it?
- PossiblyBenefit could partly reflect glycaemic, blood-pressure and weight effects; the abstract does not report mediation analysis. Dose (1.0 mg) is below obesity doses.
- Study tier
- Study tier 1Large placebo-controlled outcome trial with hard kidney endpoints; early termination is a recognised source of effect inflation.
- Assessment
- Version 2 · curated · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
In 3,533 people with type 2 diabetes and kidney disease, semaglutide 1.0 mg weekly reduced major kidney events by about a quarter and all-cause death by a fifth over 3.4 years. The trial was stopped early for benefit. It applies to people with diabetic kidney disease, not to healthy kidneys.
01Findings
What the study reported
- Drugs
- Semaglutide
- Dose
- 1.0 mg once weekly
- Route
- subcutaneous
- Treatment duration
- median 3.4 years
- Comparator
- placebo
- Primary outcome
- Major kidney disease events (kidney failure, >=50% eGFR reduction, kidney or CV death)
- Effect
- HR 0.76 (331 vs 410 events); all-cause death HR 0.80
- 95% confidence interval
- 0.66 to 0.88
- P value
- 0.0003
- Follow-up
- median 3.4 years (stopped early for efficacy)
- Adverse events
- Serious adverse events lower with semaglutide (49.6% vs 53.8%).
- Limitations
- Diabetic CKD population; early stopping.
Who was studied
- Obesity status
- not an entry criterion (mean BMI ~32 in full text)
- Diabetes status
- type 2 diabetes required (all)
- Cvd status
- mixed
- Ckd status
- CKD with albuminuria required (eGFR 25-75)
- Baseline condition
- chronic kidney disease
- Sample size
- 3533
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 3533
- Randomization
- yes
- Blinding
- double-blind
- Comparator
- placebo
- Follow up duration
- 3.4 years
- Outcome type
- mixed
- Replication
- consistent with kidney signals in SUSTAIN-6/LEADER and meta-analysis (PMID 39608381)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- INDIRECT
- Statistical precision
- CI reported: 95% confidence interval [CI], 0
- Risk of bias
- early stopping at interim analysis may overestimate effect size
- Funding conflicts
- yes
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- Novo Nordisk (NIH support listed in PubMed grant fields)
- Industry funded
- Yes
- Manufacturer
- Novo Nordisk
- Sponsor role
- Sponsor-designed and sponsor-analysed trial with academic steering committee.
- Author conflicts
- Authors report Novo Nordisk relationships; sponsor employees co-authored (see disclosures).
- Independent replication
- no; class-level consistency
- Notes
- Pivotal industry trial.
Funding is shown on every study and never used to score it.
03Claims
Claims this study bears on
- GLP-1 receptor agonists protect kidney function in people without diabetes.Supports
FLOW: HR 0.76 for major kidney events in T2D+CKD; stopped early for efficacy (may overestimate).
04Source
The source, as retrieved
Abstract
[BACKGROUND] Patients with type 2 diabetes and chronic kidney disease are at high risk for kidney failure, cardiovascular events, and death. Whether treatment with semaglutide would mitigate these risks is unknown. [METHODS] We randomly assigned patients with type 2 diabetes and chronic kidney disease (defined by an estimated glomerular filtration rate [eGFR] of 50 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio [with albumin measured in milligrams and creatinine measured in grams] of >300 and <5000 or an eGFR of 25 to <50 ml per minute per 1.73 m2 and a urinary albumin-to-creatinine ratio of >100 and <5000) to receive subcutaneous semaglutide at a dose of 1.0 mg weekly or placebo. The primary outcome was major kidney disease events, a composite of the onset of kidney failure (dialysis, transplantation, or an eGFR of <15 ml per minute per 1.73 m2), at least a 50% reduction in the eGFR from baseline, or death from kidney-related or cardiovascular causes. Prespecified confirmatory secondary outcomes were tested hierarchically. [RESULTS] Among the 3533 participants who underwent randomization (1767 in the semaglutide group and 1766 in the placebo group), median follow-up was 3.4 years, after early trial cessation was recommended at a prespecified interim analysis. The risk of a primary-outcome event was 24% lower in the semaglutide group than in the placebo group (331 vs. 410 first events; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.88; P = 0.0003). Results were similar for a composite of the kidney-specific components of the primary outcome (hazard ratio, 0.79; 95% CI, 0.66 to 0.94) and for death from cardiovascular causes (hazard ratio, 0.71; 95% CI, 0.56 to 0.89). The results for all confirmatory secondary outcomes favored semaglutide: the mean annual eGFR slope was less steep (indicating a slower decrease) by 1.16 ml per minute per 1.73 m2 in the semaglutide group (P<0.001), the risk of major cardiovascular events 18% lower (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = 0.029), and the risk of death from any cause 20% lower (hazard ratio, 0.80; 95% CI, 0.67 to 0.95, P = 0.01). Serious adverse events were reported in a lower percentage of participants in the semaglutide group than in the placebo group (49.6% vs. 53.8%). [CONCLUSIONS] Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney disease. (Funded by Novo Nordisk; FLOW ClinicalTrials.gov number, NCT03819153.).
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 38785209 first ingestion |