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.
This will be a Phase IV, randomized, parallel, active-controlled, double-blind clinical trial, with one group receiving oral Semaglutide and the other group receiving oral sitagliptin, while continuing any background glucose-lowering medications such as metformin or insulin. Treatment duration will be 26 weeks. Sitagliptin has been chosen as comparator since it is an established oral antidiabetic drug (OAD) within the DPP-4i drug class. There will be a screening period, treatment period, and follow-up period. Furthermore, the investigators will collect biological samples and correlates including serum, plasma, and Intestinal Microbiome samples prior to initiation of study treatment and at the completion of the trial. The investigators will also perform Transient Elastography at these same visits to evaluate change in degree of participant graft steatosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
The participants will be provided with Semaglutide, titrated up to 14 mg. The starting dose of Semaglutide is 3 mg once daily. At week 4, the dose will be increased to 7 mg once daily. At week 8, the dose will be increased to 14 mg once daily and will be maintained at 14mg until End of Treatment (week 26). Throughout the 26 week treatment period, participants in this arm will also take one "sitagliptin placebo" tablet per day.
participants will take 100mg tablet of Sitagliptin once daily, along with a "semaglutide placebo" pill for the duration of the 26 week treatment period
Toronto General Hospital
Toronto, Ontario, Canada
Change in HbA1c level
Evaluate the change in glycemic control and body weight within and between study groups by measuring HbA1c levels and body weight (kg)
Time frame: Baseline to 26 weeks
Change in body weight (kg)
Evaluate the change in glycemic control and body weight within and between study groups by measuring HbA1c levels and body weight (kg)
Time frame: Baseline to week 26
Change in fasting plasma glucose
Time frame: Baseline to 26 weeks
Change in body weight %
Time frame: Baseline to 26 weeks
Change in Body mass index (BMI)
Time frame: Baseline to 26 weeks
Change in waist circumference
Time frame: Baseline to 26 weeks
Number of treatment-emergent adverse events
safety and tolerability of study drugs.
Time frame: 26 weeks
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