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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the impact of the diabetes medication ertugliflozin on heart and kidney health in people with type 2 diabetes. Researchers are particularly interested in how varying levels of salt intake may alter the drug's effects. Participants will follow either a high or low salt diet while receiving the medication or a placebo. The trial seeks adults with type 2 diabetes who have stable blood sugar control and are currently on diabetes medication. As a Phase 4 trial, this research helps determine how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

Participants need to be on a stable dose of their current diabetes and hypertension medications. However, if you are taking SGLT2 inhibitors, TZD, GLP-1RA, or certain other medications, you may need to stop them. Diuretics can only be continued if they can be stopped for the study duration.

What is the safety track record for Ertugliflozin?

Research has shown that ertugliflozin is generally well tolerated by people with type 2 diabetes. In studies, most patients experienced few issues with the treatment. However, some side effects have occurred. For example, there is a risk of developing ketoacidosis, a condition characterized by excessive acid in the blood. Serious urinary tract infections have also been reported.

Despite these concerns, many clinical trials have provided a comprehensive understanding of ertugliflozin's overall safety. This allows doctors to assess its safety for patients effectively. Discussing the risks and benefits with a healthcare provider is important before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ertugliflozin for type 2 diabetes because it targets the SGLT2 protein in the kidneys, which helps lower blood sugar by removing excess glucose through urine. This mechanism is different from many traditional diabetes treatments, like metformin or insulin, which focus on either enhancing insulin sensitivity or supplementing insulin levels. Additionally, ertugliflozin can aid in weight loss and reduce blood pressure, offering potential benefits beyond blood sugar control. These features make it a promising option for those managing type 2 diabetes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that ertugliflozin effectively treats type 2 diabetes. Studies indicate it significantly lowers blood sugar levels, with an average drop in fasting blood sugar of about 1.62 mmol/L compared to a placebo. It also reduces the risk of hospital stays and deaths related to heart issues in people with type 2 diabetes. Additionally, ertugliflozin lowers HbA1c (which measures average blood sugar over time), body weight, and blood pressure, while generally maintaining stable kidney function. These findings suggest that ertugliflozin is a strong option for managing type 2 diabetes and its complications. Participants in this trial will receive either ertugliflozin or a placebo, combined with either a high or low salt diet, to further evaluate its effectiveness and safety. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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

Ability to provide signed and dated, written informed consent

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

Sodium intake at baseline <200 mmol/day

Exclusion Criteria

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

Allergy to study agents

I am currently receiving treatment for cancer, excluding hormone therapy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8902385/

Effectiveness and safety of ertugliflozin for type 2 diabetes When compared with a placebo, ertugliflozin significantly reduced fasting plasma glucose by −1.62 mmol/L (weighted mean difference, 95% CI −1.82 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2004967

Cardiovascular Outcomes with Ertugliflozin in Type 2 ... The cardiovascular effects of ertugliflozin, an inhibitor of sodium–glucose cotransporter 2, have not been established.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0147956325001293

Long-term effectiveness of SGLT2 inhibitors in type 2 ... High adherence to SGLT2 inhibitors therapy can significantly decrease the risk of cardiovascular-related hospitalization and death in patients with T2DM.

4. drc.bmj.com drc.bmj.com/content/9/1/e002484

Glycemic efficacy and safety of the SGLT2 inhibitor ... In VERTIS CV patients with CKD stage 3A, ertugliflozin resulted in reductions in HbA1c, body weight and SBP, maintenance of eGFR, and was generally well ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.050255

Efficacy of Ertugliflozin on Heart Failure–Related Events in ... In patients with type 2 diabetes mellitus, ertugliflozin reduced the risk for first and total HHF and total HHF/CV death, adding further support ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32372382/

Safety of Ertugliflozin in Patients with Type 2 Diabetes ... Conclusion: This pooled analysis showed that ertugliflozin was generally well tolerated in a large population of patients with T2DM with and ...

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-revises-labels-sglt2-inhibitors-diabetes-include-warnings-about-too-much-acid-blood-and-serious

FDA revises labels of SGLT2 inhibitors for diabetes to ... FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections.

8. link.springer.com link.springer.com/article/10.1007/s13300-020-00803-3

Safety of Ertugliflozin in Patients with Type 2 Diabetes ... Ertugliflozin was generally well tolerated in a large general population of patients with T2DM taking a range of background diabetes medications ...

9. amjmed.com amjmed.com/article/S0002-9343(19)30675-8/abstract

Safety of Sodium-Glucose Co-Transporter 2 Inhibitors Sodium-glucose co-transporter 2 (SGLT2) inhibitors have a well-defined safety profile based on data obtained from numerous clinical trials, ...