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

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510257-42-01

Enrollment

Registered

2024-10-03

Start date

2023-07-25

Completion date

2025-11-30

Last updated

2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Brief summary

To investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes.

Detailed description

GFR by iohexol clearance  Hematocrit  Office blood pressure  Kidney oxygenation  Parameters of intra kidney hemodynamic function including ERPF by p-aminohippurate (PAH) clearance and renal vascular resistance  Body anthropometrics  Fasting plasma glucose  Albumin excretion rate (24 hour)  24-hr urinary glucose excretion  Urinary and plasma biomarkers

Interventions

DRUGSteglatro 15 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes.	—

Secondary

Measure	Time frame
GFR by iohexol clearance  Hematocrit  Office blood pressure  Kidney oxygenation  Parameters of intra kidney hemodynamic function including ERPF by p-aminohippurate (PAH) clearance and renal vascular resistance  Body anthropometrics  Fasting plasma glucose  Albumin excretion rate (24 hour)  24-hr urinary glucose excretion  Urinary and plasma biomarkers	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026