Semaglutide vs Sitagliptin (NCT05195944) | Clinical Trial Compass
By InvitationPhase 4
Semaglutide vs Sitagliptin
Canada58 participantsStarted 2022-10-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 6.5-10.5% (53-91 mmol/mol) (both inclusive, not under optimal glycemic control).
For purposes of clarification, patients on stable treatment with one of the following insulin regimens (minimum 10 IU/day) ≥ 90 days prior to the day of screening, may be included (maximum 20% change in total daily dose within the 90 days is acceptable):
* Basal insulin alone
* Basal and bolus insulin in any combination
* Premixed insulin including combinations of soluble insulin Concomitant treatment with stable daily dose of metformin and/or an SGLT2 inhibitor ≥ 90 days prior to the day of screening is allowed.
Being on insulin,…