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

Trial Summary

What is the purpose of this trial?

This study will look at control of blood sugar levels in persons with type 2 diabetes mellitus currently on chronic dialysis. Researchers will compare blood sugar levels in people taking semaglutide to people taking "dummy" medicine. The treatment participants get will be decided randomly. Participants will need to inject the study medication once a week. The study will last for 1 year and a month. Participants will be asked to wear a sensor that measures blood sugar levels for a period of 10 days at five different time points during the study.

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 data supports the effectiveness of the drug semaglutide for type 2 diabetes with dialysis?

Research shows that semaglutide, a type of drug called a GLP-1 receptor agonist, is effective in improving blood sugar control and has additional benefits like reducing blood pressure and weight. It has been used safely in patients with advanced kidney disease, which suggests it could be beneficial for those on dialysis. ^{1 2 3 4 5}

Is semaglutide safe for people with type 2 diabetes, including those on dialysis?

Semaglutide, used for type 2 diabetes, has been shown to be generally safe in various studies, including those with kidney issues. It helps control blood sugar and may also aid in weight loss and heart health, with a safety profile similar to other drugs in its class. ^{1 2 6 7 8}

How is the drug semaglutide unique for treating type 2 diabetes in patients on dialysis?

Semaglutide is unique because it is a glucagon-like peptide-1 receptor agonist (GLP-1RA) that can be used in patients with advanced chronic kidney disease (CKD) and those on dialysis, offering benefits like improved blood sugar control, weight loss, and preservation of kidney function, which are not commonly addressed by other diabetes treatments. ^{1 2 6 8 9}

Research Team

Ildiko Lingvay, MD, MPH, MSCS

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. [2022]

4. United States 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. [2022]

5. England 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. [2022]

6. Belgium pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. Switzerland 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. [2018]

9. Belgium pubmed.ncbi.nlm.nih.gov

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