NCT06983054

DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incompletely understood and the salutary effect may be altered by dietary factors such as sodium intake. Therefore, carefully designed mechanistic trials are needed to better understand the interplay between ertugliflozin and salt intake and to potentially modify salt intake to maximize treatment response. In addition, the study could contribute to hypotheses concerning the effects of SGLT2 inhibitors in combination with other drugs that affect sodium homeostasis and could help to explain the differences in kidney outcomes observed in (outcome) trials, which include different ethnicities with potential differences in dietary habits.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	ertugliflozine	SGLT2i versus placebo
BEHAVIORAL	low salt diet	comparing low salt versus high salt diet
DRUG	placebo	placebo tablet
BEHAVIORAL	high salt diet	high salt diet

Timeline

• Start date: 2023-07-25
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

2 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated drug study