Ertugliflozin for Type 2 Diabetes

(DESIGN Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Amsterdam UMC, location VUmc

Must be taking: Diabetes medication, RAS inhibitors

Must not be taking: SGLT2 inhibitors, GLP-1RA

Disqualifiers: Renal disease, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people with type 2 diabetes who are interested in how a low or high salt diet might affect their treatment. Participants should be willing to take the drug Ertugliflozin and follow specific dietary instructions. The study excludes individuals if they have other health conditions that could interfere with the trial's process or results.

Inclusion Criteria

UACR <30 mg/mmol

Ability to provide signed and dated, written informed consent

Estimated GFR 60-90 ml/min/1.73m2 by CKD-EPI

Exclusion Criteria

I have had heart disease or a stroke in the last 6 months.

Allergy to study agents

I currently have a urinary tract infection and kidney inflammation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention and Treatment

Participants undergo dietary interventions with either high or low salt intake and receive either placebo or SGLT2i treatment for 10 days during a 20-day diet period

20 days

Cross-over

Participants switch to the alternate diet and treatment arm for another 20-day period

20 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ertugliflozin

Trial Overview The DESIGN study tests how different levels of salt intake (low vs high) influence the effects of Ertugliflozin, a medication used for type 2 diabetes, on kidney function and blood flow. It's a controlled experiment where participants will also receive placebos at some point, and treatments will be swapped over time.

Participant Groups

Group I: Low salt diet with SGLT2i Active Control 2 Interventions

10 days of SGLT2i treatment during 20 days of low salt diet

Group II: High salt diet with SGLT2i Active Control 2 Interventions

10 days of SGTL2i during 20 days of high salt diet.

Group III: High salt diet with placebo Placebo Group 2 Interventions

10 days of placebo during 20 days of high salt diet.

Group IV: Low salt diet with placebo Placebo Group 2 Interventions

10 days of placebo during 20 days of low salt diet

Who Is Running the Clinical Trial?

Amsterdam UMC, location VUmc

Lead Sponsor

Trials

421

Recruited

218,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+