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Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide vs Sitagliptin for Diabetes After Liver Transplant

Phase 4

Waitlist Available

Led By Mamatha Bhat, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recipient of liver graft (Liver/Kidney recipients and retransplants allowed)

Patient diagnosed with type 2 diabetes or post-transplant diabetes

Must not have

Known history of proliferative retinopathy or maculopathy requiring acute treatment, unless stable

Planned coronary, carotid or peripheral artery revascularization known on the day of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trialwill compare the effectiveness of two diabetes treatments in people who have had liver transplants and have poor blood sugar control.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include digestive problems like nausea or diarrhea, low blood sugar events, potential allergic reactions to the medications, and changes in insulin levels which might affect overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received a liver transplant.

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I have been diagnosed with type 2 diabetes or diabetes after a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am scheduled for a procedure to improve blood flow to my heart or other areas.

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I have had pancreatitis before.

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I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

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I have not had major stomach surgery that could affect medication absorption.

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My heart condition severely limits my physical activity.

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I have had a transplant for a condition like amyloidosis or cystic fibrosis.

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My kidney function is very low, with an eGFR below 30.

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I am currently experiencing issues with a transplanted organ.

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I am currently taking steroids for acute cellular rejection.

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I or my family have a history of MEN 2 or Medullary Thyroid Carcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c level (%)

Secondary study objectives

Change in body weight (kg)

Number of treatment-emergent adverse events

Other study objectives

Change in alanine aminotransferase (ALT) level

Change in aspartate aminotransferase (AST) level

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SemaglutideExperimental Treatment1 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: SitagliptinActive Control1 Intervention

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

0 / 13Eligibility criteria met