Semaglutide for Type 2 Diabetes with Dialysis

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Ildiko Lingvay, MD, MPH, MSCS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

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

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}

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

Trial 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 (Placebo)
• Semaglutide (GLP-1 Receptor Agonist)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

DaVita UT Southwestern - Irving Irving, TX

DaVita UT Southwestern - East Dallas Dallas, TX

DaVita UT Southwestern - Preston Dallas, TX

Davita UT Southwestern - Oak Cliff Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center Lead Sponsor

University of North Carolina, Chapel Hill Collaborator

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] The glucagon-like peptide-1 receptor agonists (GLP-1RA) are among the newest treatment options available for managing of type 2 diabetes mellitus and slowing the progression of diabetes kidney disease (DKD). Subcutaneous (SC) semaglutide (Ozempic®) is a GLP-1RA with an extended half-life of approximately 1 week. GLP-1RA are highly effective in improving glycemic control and also show other beneficial effects such as increased natriuresis; decreased blood pressure and albuminuria; reduction of oxidative stress and inflammation; delay of gastric emptying and suppress appetite; the latter may result in significant weight loss. GLP-1RA can be used in patients with advanced-stage CKD; the European Medicines Agency has approved the use of all commercially available human GLP-1 analogs up to a minimal eGFR of 15 mL/min/1.73 m2. However, studies of safety and use of these agents in renal replacement therapy are scarce. Therefore, herein we present 3 cases of patients with advanced DKD in maintenance incremental hemodialysis with 1 session per week to describe the efficacy and safety of the SC semaglutide treatment and the favorable effects on glycemic control, lowering HbA1c, albuminuria, weight, blood pressure control, and preservation of residual kidney function (RKF) during a 6-month follow-up in a hospital hemodialysis unit in Spain. These effects could produce an improvement in morbidity and mortality and could also prevent albuminuria and preserve the RKF. This may allow our patients to maintain a weekly hemodialysis session and could facilitate their inclusion in the kidney transplant waiting lists.

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

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. [2023] To explore the effects of oral semaglutide on glycaemic parameters, body weight, and satisfaction in the first recipient patients with type 2 diabetes mellitus in Slovenia, in a real-world clinical practice setting.

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] To evaluate the efficacy and safety of oral semaglutide versus comparators by patient characteristic subgroups in patients with type 2 diabetes.

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] To investigate the safety and efficacy of once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide as monotherapy or add-on to other antihyperglycaemic agents (AHAs) in patients with type 2 diabetes mellitus (T2DM).

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] Despite a broad range of pharmacological options for the treatment of type 2 diabetes, optimum glycaemic control remains challenging for many patients and new therapies are necessary. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue in phase 3 development for type 2 diabetes. We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.

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

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022] Oral semaglutide (Rybelsus®) is a co-formulation of semaglutide, a glucagon-like peptide-1 (GLP-1 RA) receptor agonist, with an absorption enhancer, sodium N- (8- [2- hydroxybenzoyl] amino) caprylate (SNAC), which facilitates the absorption of semaglutide across the gastric epithelium in a concentration dependent manner. The safety and efficacy of oral semaglutide were assessed in the PIONEER clinical trial programme, which included 9543 patients with type 2 diabetes (T2DM). Across a range of different T2DM patients receiving different background medications, oral semaglutide provides more effective glycaemic control than common oral glucose-lowering therapies, associated with a clinically relevant reduction in body weight, including in patients with more advanced T2DM on insulin treatment. The tolerability profile for oral semaglutide was consistent with the other GLP-1 RAs. Cardiovascular (CV) safety of oral semaglutide was noninferior to placebo in CV high-risk patients. Available in three doses (3, 7 and 14 mg) to be gradually increased, Rybelsus® is currently reimbursed in Belgium after failure of antidiabetic treatment (including metformin; HbA1C superior to 7.5 % or 58 mmol/mol) in T2DM patients with a body mass index ? 30 kg/m².

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

A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes. [2023] T2DM (type 2 diabetes mellitus) is a chronic and progressive illness with high morbidity and death rates. Oral semaglutide (Rybelsus®) is a combination of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), and sodium N- (8- [2-hydroxybenzoyl] amino) caprylate (SNAC), an absorption enhancer that facilitates semaglutide absorption across the gastric epithelium in a concentration-dependent manner. This family of drugs apart from glucose lowering effects causes significant weight loss with lower risk of hypoglycemia, and some of them have been linked to a significant reduced major adverse cardiovascular events. GLP-1 RAs may assist persons with T2DM and chronic kidney disease (CKD), a major microvascular consequence of T2DM, in ways other than lowering blood sugar. Several large clinical studies, the bulk of which are cardiovascular outcome trials, show that GLP-1 RA treatment is safe and tolerated for persons with T2DM and impaired renal function and that it may potentially have renoprotective characteristics. This article focuses on the advances of oral GLP1-RA and describes the key milestones and predicted advantages.

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] The pharmacokinetics and tolerability of semaglutide, a once-weekly human glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus, were investigated in subjects with/without renal impairment (RI).

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

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019] Semaglutide (Ozempic®) is a new once-weekly agonist of glucagon-like peptide-1 receptors (GLP-1 AR) indicated in the treatment of type 2 diabetes (T2D). Phase III clinical trials of the SUSTAIN programme demonstrated both the efficacy and safety of semaglutide in patients with T2D treated by diet and exercise, oral antidiabetic agents or even insulin. Direct and indirect comparative clinical trials showed that semaglutide (subcutaneous 0.5 or 1.0 mg once weekly) exerts a better glucose-lowering activity and a greater weight loss than other GLP-1 AR. Presented as prefilled pens for subcutaneous injection, semaglutide is currently reimbursed in Belgium after failure of antidiabetic therapy including metformin (HbA1c superior to 7,5 % or 58 mmol/mol) in T2D patients with body mass index ? 30 kg/m².