Semaglutide vs Sitagliptin for Diabetes After Liver Transplant

Overseen By Mamatha Bhat, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University Health Network, Toronto

Must not be taking: Diabetes medications, Obesity medications

Disqualifiers: Pregnancy, Pancreatitis, Heart disease, 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 explores how two medications, Semaglutide and Sitagliptin, affect blood sugar control and weight in people with diabetes who have undergone a liver transplant. Participants will take one of these medications daily for about six months to determine which is more effective and safer. The trial seeks liver transplant recipients with poorly controlled diabetes. Eligible participants must have received their transplant at least three months ago and not be experiencing any active rejection issues. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments benefit a broader range of 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. However, you can continue taking insulin, metformin, and/or an SGLT-2 inhibitor if you've been on a stable dose for at least 90 days before screening.

What is the safety track record for these treatments?

Earlier studies have shown that semaglutide is safe and well-tolerated in people with diabetes who have had a liver transplant. Research indicates it aids in weight loss and is generally effective without causing serious side effects. Some studies reported minor issues like nausea and vomiting, but these were uncommon.

For sitagliptin, research shows it is also safe for managing diabetes. Studies have found it can help lower blood sugar levels over several months. However, rare cases of liver problems have been reported. Overall, sitagliptin is usually considered safe, but monitoring liver health is important.

Both treatments have been studied and shown to be generally safe, but like any medication, side effects can occur. Always consult your doctor to determine what might be right for you. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Semaglutide for managing diabetes after a liver transplant because it offers a unique approach compared to standard treatments like Sitagliptin. Unlike typical diabetes medications that primarily focus on insulin regulation, Semaglutide targets GLP-1 receptors, which can enhance insulin secretion and reduce blood sugar levels. This mechanism not only helps in better glucose control but may also support weight loss, offering a dual benefit for patients. Additionally, with dosing options up to 14 mg, Semaglutide provides flexible management tailored to individual patient needs.

What evidence suggests that this trial's treatments could be effective for diabetes after liver transplant?

This trial will compare Semaglutide and Sitagliptin for managing diabetes after a liver transplant. Research has shown that Semaglutide is effective and safe for treating diabetes in liver transplant recipients, aiding in weight loss and better blood sugar control. One study found that patients lost about 8% of their body weight over a year while using Semaglutide. Sitagliptin has also been proven safe and effective for managing diabetes in transplant patients, improving blood sugar levels and liver function. Participants in this trial will receive either Semaglutide or Sitagliptin, both promising options for managing diabetes after a liver transplant. ^{1 2 4 6 7}

Who Is on the Research Team?

Mamatha Bhat, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

Adults over 18 who've had a liver transplant at least 3 months ago, have type 2 or post-transplant diabetes with HbA1c levels between 7.0-10.5%, and stable liver enzymes can join this trial. They must not have severe heart issues, recent cancer (except certain types), or be pregnant, among other criteria.

Inclusion Criteria

I am currently on an immunosuppression regimen.

I have received a liver transplant.

Willing and able to provide informed consent

Exclusion Criteria

You have known or suspected allergies to the trial products or similar products.

My eye condition is stable and doesn't need immediate treatment.

I haven't taken diabetes or obesity drugs not listed in the criteria in the last 90 days, except for a short insulin change.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral Semaglutide or Sitagliptin for 26 weeks

26 weeks

Regular visits for biological sample collection and transient elastography

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide Treatment
• Sitagliptin 100mg

Trial Overview

The trial is testing the effectiveness of oral Semaglutide versus Sitagliptin in controlling blood sugar and body weight in liver transplant recipients with poor diabetes control. Each medication is taken once daily.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

In the Semaglutide Arm, participants will receive daily: 1 tablet of Semaglutide and 1 tablet of Sitagliptin placebo for 26 weeks. The dosages of Semaglutide are 3 mg, 7 mg, and 14 mg.

Group II: Sitagliptin Active Control 1 Intervention

In the Sitagliptin arm, participants will receive daily: 1 tablet of 100 mg Sitagliptin and 1 tablet of Semaglutide placebo for 26 weeks.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Novo Nordisk A/S

Industry Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05424003

Study Details | NCT05424003 | Randomized Double ...

The purpose of this research study is to test the safety, tolerability, and effectiveness of semaglutide when used to prevent weight gain after liver transplant ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1590865825010011

Impact of GLP1-receptor agonists on diabetes after liver ...

In this single-center retrospective analysis, we showed that, in LTR with diabetes, weekly GLP1-RAs therapy is safe and induces early and relevant weight loss ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37639288/

Semaglutide is effective in achieving weight loss in liver ...

Semaglutide is effective in achieving weight loss in liver transplant recipients.

4.

journals.lww.com

journals.lww.com/ajg/fulltext/2023/10001/s1318_semaglutide_is_effective_in_achieving_weight.2279.aspx

S1318 Semaglutide Is Effective in Achieving Weight Loss in...

We demonstrated that in our cohort of OLT recipients, the use of Semaglutide led to a substantial decrease in weight. Given the high prevalence of post-OLT ...

5.

elsevier.es

elsevier.es/en-revista-annals-hepatology-16-articulo-semaglutide-for-treatment-post-transplantation-S1665268125001450

Semaglutide for the treatment of post transplantation ...

In conclusion, semaglutide seems effective, well-tolerated and safe in the treatment of PTDM in patients following liver transplantation. Therefore, GLP-1RA ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12148859/

Glucagon-like peptide-1 receptor agonists in liver transplant ...

In conclusion, GLP1RA-based therapy can be considered safe and effective in a short-term follow up in liver-transplanted patients. Further ...

7.

amjtransplant.org

amjtransplant.org/article/S1600-6135(25)00862-7/fulltext

Long-Term Outcomes of GLP-1 Use After Liver and ...

CV event rates post GLP-1 were reported in 15% of patients. Rates of graft loss and mortality were low at 1.3% and 10% respectively at 5 years. GLP-1 adverse ...