Semaglutide for Patients on Dialysis

(GUARD-1 Trial)

Overseen By Kevin Yau, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Unity Health Toronto

Must be taking: Oral hypoglycemics, Insulin

Must not be taking: GLP-1-RA

Disqualifiers: Type 1 DM, Pregnancy, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests semaglutide, a medication used to manage blood sugar levels, in individuals on dialysis who also have type 2 diabetes. The researchers aim to determine if semaglutide is safe and tolerable for these patients and whether it could lead to a larger study focused on heart health. Participants will either receive semaglutide once a week or continue with their usual diabetes care for 26 weeks. This trial suits individuals who have been on dialysis for at least 90 days and currently manage type 2 diabetes. As a Phase 4 trial, semaglutide is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot have used a GLP-1-RA (a type of diabetes medication) within 30 days before the trial.

What is the safety track record for semaglutide?

In a previous study, patients with kidney problems took semaglutide for about 17.4 months. Nearly two-thirds, or 63.1%, experienced no side effects, suggesting that semaglutide is generally safe for individuals with kidney issues. However, reactions can vary, and some may experience side effects. The FDA has already approved semaglutide for other conditions, indicating it has passed several safety checks for those uses. Always consult your doctor to determine if joining a trial is suitable for you. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about semaglutide for patients on dialysis because it offers a potentially groundbreaking approach for managing type 2 diabetes in this group. Unlike other treatments that typically involve frequent insulin injections, semaglutide is administered just once a week, which could improve compliance and quality of life. Additionally, semaglutide is a GLP-1 receptor agonist, which not only helps control blood sugar levels but may also provide cardiovascular benefits, a critical consideration for patients on dialysis. This dual action makes it a promising option for patients who need more than just blood sugar management.

What evidence suggests that semaglutide might be an effective treatment for patients on dialysis?

Research has shown that semaglutide can benefit people with kidney problems. One study found that individuals with chronic kidney disease (CKD) who took semaglutide lost an average of 5.1 kg, or about 4.7% of their body weight. This weight loss is significant because maintaining a healthy weight supports kidney health. Additionally, semaglutide has protected the kidneys in people with type 2 diabetes, potentially benefiting those on dialysis. In this trial, participants in the semaglutide group will take the medication once weekly. Furthermore, semaglutide has helped individuals with obesity on dialysis lose weight and lower their body mass index (BMI), while remaining safe to use. These findings suggest that semaglutide could improve health in this population. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 Diabetes who are also receiving maintenance dialysis due to chronic kidney disease or failure. Participants should be able to follow the study procedures and willing to inject medication weekly.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with type 2 diabetes and have taken diabetes medication.

Ability to provide informed consent or through their substitute decision maker

Exclusion Criteria

Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA

Type 1 DM

Known hypersensitivity to GLP-1-RA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly subcutaneous semaglutide or usual care for 26 weeks

26 weeks

Visits at 0, 4, 8, and 12 weeks for training/re-training on injector use

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The trial tests if a diabetes medication, Semaglutide Pen, given once a week by injection, is safe for those on dialysis. Half of the participants will receive Semaglutide while the other half will continue their usual care without it.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Individuals randomized to this arm will take semaglutide once weekly.

Group II: Usual Care Group Active Control 1 Intervention

This treatment arm comprises a strategy of usual care for type 2 diabetes mellitus

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39025300/

The Use of Semaglutide in Patients With Renal Failure-A ... Patients received semaglutide for a median duration of 17.4 (IQR 0.43, 48.8) months. Forty-eight (63.1%) patients reported no adverse effects ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1530891X24006062

The Use of Semaglutide in Patients With Renal Failure-A ... The study shows an average of 5.1 kg weight loss (4.7% of total body weight loss) with semaglutide use in people with CKD 4 or greater; this is consistent with ...

3. nature.com nature.com/articles/s41591-024-03015-5

Long-term kidney outcomes of semaglutide in obesity and ... These results suggest a benefit of semaglutide on kidney outcomes in individuals with overweight/obesity, without diabetes.

4. academic.oup.com academic.oup.com/ckj/article/18/8/sfaf227/8196614

Effects of oral semaglutide on kidney outcomes in people with ... Subcutaneous semaglutide has shown kidney-protective effects in people with type 2 diabetes (PWT2D), but data on oral semaglutide remain limited ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15967

Semaglutide in patients with kidney failure and obesity ... Semaglutide treatment resulted in significant reduction in weight and BMI in patients with obesity undergoing dialysis, while maintaining an acceptable side ...

6. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2403347

Effects of Semaglutide on Chronic Kidney Disease in ... The risk of a primary-outcome event was 24% lower in the semaglutide group than in the placebo group (331 vs. 410 first events; hazard ratio, ...