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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
Male or female, age ≥18 years at the time of signing informed consent
The use of any immunosuppression regimen (calcineurin inhibitors, mycophenolate mofetil, maintenance prednisone or sirolimus) is acceptable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am 18 years or older and have given my consent.
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I am currently on an immunosuppression regimen.
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I have received a liver transplant.
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I had a liver transplant for cancer and my latest scans show no signs of cancer returning.
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It's been over 3 months since my transplant, no rejection, and my liver is mostly stable.
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I have been diagnosed with type 2 diabetes or diabetes after a transplant.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c level (%)
Secondary outcome measures
Change in body weight (kg)
Number of treatment-emergent adverse events
Other outcome measures
Change in alanine aminotransferase (ALT) level
Change in aspartate aminotransferase (AST) level

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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,659 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
100 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Novo Nordisk A/SIndustry Sponsor
1,503 Previous Clinical Trials
2,385,674 Total Patients Enrolled
17 Trials studying Non-alcoholic Fatty Liver Disease
4,205 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Mamatha Bhat, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Semaglutide Treatment (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05195944 — Phase 4
Non-alcoholic Fatty Liver Disease Research Study Groups: Semaglutide, Sitagliptin
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Semaglutide Treatment Highlights & Side Effects. Trial Name: NCT05195944 — Phase 4
Semaglutide Treatment (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05195944 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities open for this scientific research?

"The clinicaltrials.gov website shows that this medical study is not currently enrolling patients, although it was initially posted on October 26th 2022 and recently updated seven days later. Despite this trial's inactivity, there are 1,423 other studies actively seeking participants at the moment."

Answered by AI

Has Semaglutide gained clearance from the FDA?

"The safety of Semaglutide is highly rated at 3, given that it has passed the Phase 4 clinical trial phase and is now approved."

Answered by AI
~0 spots leftby Apr 2024