Albuminuria Responses to Dapagliflozin in Patients With Type 2 Diabetes: A Crossover Trial
Primary result · Relative change in UACRResult — go to the resultRelative change −15.1 % 95% CI −28.2% to −3.3%Authors' conclusion
In this crossover trial, individual UACR responses to dapagliflozin reflected a pharmacological response. Remote data collection proved to be reliable, supporting its use in future studies and clinical practice for monitoring individual dapagliflozin responses.
Study context
- Population
- Adults with T2D, urine albumin-to-creatinine ratio (UACR) >20 mg/g and estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m², Dutch primary and secondary care, May 2021–September 2022crossover
- Participants
- 20 adults
- Comparison
- Dapagliflozin 10 mg/d vs placebo
- Primary endpoint
- Difference in change in UACR from start to end of treatment between dapagliflozin and placebo, per-protocol population
Methodological detailsdecentralized, double-blind, placebo-controlled, crossover, n-of-1
- Decentralized
- Double-blind
- Placebo-controlled
- Crossover
- n-of-1
Primary result
Relative change in UACR
Relative change
−15.1 %
95% CI −28.2% to −3.3%
P = 0.01
Dapagliflozinvs Placebo
relative change −15.1 % (95% CI −28.2% to −3.3%); P = 0.01
As reported in the abstract
Further findings
| Outcome | Dapagliflozin | Placebo |
|---|---|---|
| UACR change, first treatment periodMedian | −12.8% (range −56.3%–36.2%) | 2.9% (range −86.7%–35.1%) |
| Correlation of UACR changes between repeated exposures | 0.50 | 0.09 |
| P | P = .03 | P = .69 |
Remote data collection: samples delivered to central laboratory
- Urine samples delivered
- 811 of 816 (99.4%)
- Capillary blood samples delivered
- 433 of 440 (98.4%)
- Post hoc exploratory analysis
Original publication
Albuminuria Responses to Dapagliflozin in Patients With Type 2 Diabetes: A Crossover Trial. JAMA Netw Open. Published 3 March 2025. doi:10. 1001/ jamanetworkopen. 2025. 1689
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