Semaglutide for Type 2 Diabetes with Dialysis

Recruiting at 4 trial locations

Overseen By Ildiko Lingvay, MD, MPH, MSCS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Glucose lowering

Must not be taking: GLP-1 RA

Disqualifiers: Thyroid cancer, Pregnancy, Pancreatitis, others

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

Compensation: Varies

Number of Visits: 5

Duration: 13 months

157 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines semaglutide to determine its effectiveness in controlling blood sugar levels in people with type 2 diabetes who are on dialysis. Participants will receive either semaglutide (known by brand names Ozempic, Wegovy, or Rybelsus) or a placebo to compare effects. This trial suits those who have had type 2 diabetes for over six months and are currently on dialysis. Participants will inject the medication weekly and wear a sensor to monitor blood sugar levels at specific times throughout the year-long study. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but it does mention that if you are taking DPP-4 Inhibitors, you will need to stop them at randomization. Other glucose-lowering medications should be stable for at least 30 days before joining the trial.

What is the safety track record for these treatments?

Research shows that semaglutide is generally well-tolerated. One study reported fewer serious side effects in people taking semaglutide compared to those on a placebo. Specifically, 49.6% of people on semaglutide experienced serious side effects, while 53.8% of those on a placebo did. Another study found that 63.1% of patients had no side effects at all. Semaglutide is also approved for treating type 2 diabetes, meeting safety standards for that condition. Overall, evidence suggests that semaglutide is safe for most people, though some might experience side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Semaglutide is unique because it offers a treatment option for people with type 2 diabetes who are also undergoing dialysis, a group that often has limited options due to their condition. Most current treatments for type 2 diabetes focus on managing blood sugar levels and often include insulin or oral medications like metformin. What sets semaglutide apart is its novel mechanism as a GLP-1 receptor agonist, which not only helps regulate blood sugar but also has potential benefits for weight management and cardiovascular health. Researchers are excited about semaglutide because it could provide a more comprehensive approach to managing diabetes in patients with complex needs, potentially improving both their quality of life and overall health outcomes.

What is the effectiveness track record for semaglutide in treating type 2 diabetes?

This trial will compare Semaglutide with a placebo for participants with type 2 diabetes undergoing dialysis. Research has shown that Semaglutide benefits people with type 2 diabetes. Studies have found that it lowers the risk of serious kidney problems and heart-related deaths in these patients. Additionally, it reduces the risk of death from any cause over three years compared to sitagliptin, another diabetes drug. Semaglutide offers kidney-protective effects, which is crucial for those with both diabetes and kidney issues. Overall, strong evidence supports Semaglutide's role in managing type 2 diabetes and protecting the kidneys. ^{1 3 4 6 7}

Who Is on the Research Team?

Ildiko Lingvay, MD, MPH, MSCS

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

Adults over 18 with type 2 diabetes on dialysis for at least 6 months, currently taking stable glucose-lowering medication can join. They must have a certain blood sugar level range and not be underweight or have used GLP-1 RA drugs recently. People with specific medical conditions, severe allergies to trial meds, pregnant or not using contraception, actively losing weight, or having other types of diabetes cannot participate.

Inclusion Criteria

Ability to provide informed consent before any trial-related activities

You need to have at least 80% of the data from a 10-day continuous glucose monitor download.

I am over 18 years old.

Exclusion Criteria

Your body mass index (BMI) is less than 23.

You have a known or suspected allergy to the trial medication (GLP-1 RA) or any related products.

Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo as an adjunct to standard-of-care for 1 year and 1 month

13 months

5 visits for sensor placement (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Semaglutide

Trial Overview The DIALYSIS-TIR Study is testing if semaglutide helps control blood sugar better than a placebo in people with type 2 diabetes who are on chronic dialysis. Participants will inject the medicine once weekly for over a year and wear a glucose sensor periodically to monitor changes.

How Is the Trial Designed?

Group I: Arm 1 - Semaglutide Experimental Treatment 1 Intervention

Participants will receive semaglutide as an adjunct to standard-of-care.

Group II: Arm 2- Placebo Placebo Group 1 Intervention

Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

Semaglutide, a once-weekly GLP-1 receptor agonist, significantly reduced HbA1c levels, self-measured plasma glucose, fasting plasma glucose, and body weight in patients with type 2 diabetes mellitus (T2DM), based on a meta-analysis of 11 studies involving 9519 participants.

While semaglutide increased the incidence of adverse events slightly, it did not significantly raise the risk of serious adverse events or hypoglycemic events compared to control, indicating it is a safe and effective option for T2DM patients, especially those with obesity or poor adherence to daily medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of once-weekly glucagon-like peptide-1 receptor agonist semaglutide in patients with type 2 diabetes mellitus: a systemic review and meta-analysis. Li, X., Qie, S., Wang, X., et al.[2022]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

In a phase 3 trial involving 388 treatment-naive patients with type 2 diabetes, semaglutide significantly reduced HbA1c levels by 1.45% with 0.5 mg and 1.55% with 1.0 mg doses compared to placebo, indicating its efficacy in improving glycaemic control.

Semaglutide also led to significant weight loss, with reductions of 3.73 kg and 4.53 kg for the respective doses, while maintaining a safety profile similar to existing GLP-1 receptor agonists, with most adverse events being mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Sorli, C., Harashima, SI., Tsoukas, GM., et al.[2022]

In a study of 20 patients with type 2 diabetes in Slovenia, oral semaglutide significantly reduced HbA1c levels and fasting plasma glucose, indicating its efficacy in improving glycaemic control.

Patients reported high satisfaction with the treatment, and while some experienced mild gastrointestinal side effects, the overall safety profile was considered good, suggesting that oral semaglutide is a promising option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. Janić, M., Jovanović, M., Janež, A., et al.[2023]

Oral semaglutide, particularly at doses of 14 mg or flexibly dosed, significantly reduced HbA1c levels and body weight in patients with type 2 diabetes compared to other treatments, especially in those with higher baseline HbA1c levels.

The safety profile of oral semaglutide was comparable to that of other treatments, although it was associated with a higher incidence of gastrointestinal adverse events, which were consistent across different patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Aroda, VR., Bauer, R., Christiansen, E., et al.[2022]

In a study involving 56 subjects with varying degrees of renal impairment, semaglutide exposure was found to be similar in those with mild to moderate renal impairment and end-stage renal disease compared to those with normal kidney function, suggesting it is safe for use in these populations.

The drug was well-tolerated overall, with no significant safety concerns or serious adverse events reported, indicating that dose adjustments for semaglutide may not be necessary for patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. Marbury, TC., Flint, A., Jacobsen, JB., et al.[2018]

Oral semaglutide (Rybelsus®), a GLP-1 receptor agonist, not only helps lower blood sugar levels in people with type 2 diabetes but also promotes significant weight loss and has a lower risk of causing hypoglycemia.

Clinical studies indicate that GLP-1 receptor agonists are safe for individuals with type 2 diabetes and chronic kidney disease, and they may offer additional benefits such as protecting kidney function and reducing the risk of major cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes. Selvarajan, R., Subramanian, R.[2023]

Subcutaneous semaglutide (Ozempic®), a GLP-1 receptor agonist, has shown significant efficacy in improving glycemic control and reducing HbA1c, albuminuria, and blood pressure in patients with advanced diabetic kidney disease (DKD) during a 6-month follow-up study involving patients on maintenance hemodialysis.

The treatment not only aids in weight loss and appetite suppression but also helps preserve residual kidney function, potentially improving patient outcomes and facilitating their inclusion on kidney transplant waiting lists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis. De la Flor, JC., Lorenzo, JD., Marschall, A., et al.[2022]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2403347

Effects of Semaglutide on Chronic Kidney Disease in ... Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40628673/

Effectiveness of semaglutide on survival outcomes in ... Conclusions: In patients with T2D and CKD, semaglutide was associated with a lower 3-year risk of all-cause death compared with sitagliptin.

3. 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12243591/

Effectiveness of semaglutide on survival outcomes in ... In patients with T2D and CKD, semaglutide was associated with a lower 3-year risk of all-cause death compared with sitagliptin.

5. diabetesjournals.org diabetesjournals.org/care/article/48/11/1878/163056/Effects-of-Semaglutide-With-or-Without-Concomitant

Effects of Semaglutide With or Without Concomitant ... Semaglutide reduced the risk of the primary kidney outcome by 49% (59 events; hazard ratio [HR] 0.51 [95% CI 0.30, 0.86]) and 21% (682 events; ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38785209/

Effects of Semaglutide on Chronic Kidney Disease in Patients ... Serious adverse events were reported in a lower percentage of participants in the semaglutide group than in the placebo group (49.6% vs. 53.8%).

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

The Use of Semaglutide in Patients With Renal Failure-A ... Forty-eight (63.1%) patients reported no adverse effects associated with the therapy. Mean weight decreased from 106.2 (SD 24.2) to 101.3 (SD 27.3) kg (P < .001) ...