Diabetes Mellitus Clinical Trial
Official title:
The GLP-1 Agonist Semaglutide for the Treatment of Metabolic Disease in Liver Transplant Recipients: A Phase IV, Randomized Trial
Verified date | November 2022 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effect of once daily dosing of oral Semaglutide versus once daily dosing Sitagliptin on glycemic control, body weight, and safety and tolerability will be compared in Liver Transplant Recipients with poorly-controlled Diabetes Mellitus.
Status | Enrolling by invitation |
Enrollment | 140 |
Est. completion date | December 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female, age =18 years at the time of signing informed consent. - Willing and able to provide informed consent. - Recipient of liver graft (Liver/Kidney recipients and retransplants allowed) - Time from transplant surgery = 3 months at time of screening visit with no evidence of active rejection. Liver enzymes must be stable with elevations no greater than 2xULN. However, if patients have elevated liver enzymes beyond 2xULN due to NASH, as confirmed on liver biopsy, they may be included. - Patient diagnosed with type 2 diabetes or post-transplant diabetes - Patients transplanted for hepatocellular carcinoma may be included provide their latest surveillance imaging is negative for recurrence - The use of any immunosuppression regimen (calcineurin inhibitors, mycophenolate mofetil, maintenance prednisone or sirolimus) is acceptable - HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive, not under optimal glycemic control). Exclusion Criteria: - Known or suspected hypersensitivity to trial products or related products. - Previous participation in this trial. - Active graft dysfunction that requires investigation (at screening). - Currently receiving steroids (prednisone) for treatment of acute cellular rejection. - Patients transplanted for multisystem genetic disorders such as amyloidosis or cystic fibrosis. - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly-effective contraceptive methods (). - Receipt of any investigational medicinal product within 90 days before screening. - Any disorder or medical condition which, in the investigator's opinion, might jeopardize patient's safety or compliance with the protocol. - Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). - History of pancreatitis (acute or chronic). - History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Any of the following: myocardial infarction (MI), stroke or hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening and randomization. - Classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularization known on the day of screening. - Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term change of insulin treatment for acute illness for a total of = 14 days. - Known history of proliferative retinopathy or maculopathy requiring acute treatment, unless stable - History or presence of actively treated malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, hepatocellular carcinoma, and carcinoma in situ.) |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Novo Nordisk A/S |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in aspartate aminotransferase (AST) level | Liver enzyme (AST) level acts as a biomarker of graft injury and will be measured through serum samples during study visits. | baseline to 26 weeks | |
Other | Change in alanine aminotransferase (ALT) level | Liver enzyme (ALT) level acts as a biomarker of graft injury and will be measured through serum samples during study visits. | baseline to 26 weeks | |
Primary | Change in HbA1c level (%) | Evaluate the change in glycemic control within and between study groups by measuring HbA1c | Baseline to 26 weeks | |
Secondary | Change in body weight (kg) | Evaluate the change in body weight within and between groups | baseline to 26 weeks | |
Secondary | Number of treatment-emergent adverse events | safety and tolerability of study drugs. | 26 weeks |
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