Evaluation of Vildagliptin for the Prevention of New-Onset Diabetes Mellitus Post-Renal Transplantation in the Early Post-Transplant Period

The primary objective of this study is to demonstrate that a short-term treatment with **vildagliptin** administered in the early post-transplant period can prevent the occurrence of post-transplant diabetes one year after kidney transplantation. This is clinically relevant as post-transplant diabetes is a common complication that can adversely affect graft survival and patient outcomes.

Secondary objectives include:

• Determining the effect of vildagliptin administration on glycemic control, specifically glycosylated hemoglobin levels, at 3, 6, and 12 months post-transplantation.
• Assessing the occurrence of acute rejection and infections one year after transplantation.
• Evaluating the correlation with health-related quality of life using the ReTRANSQOL questionnaire at 8 days, 3 months, 6 months, and 12 months post-transplantation.
• Analyzing the cost-effectiveness ratio in both groups of patients.

The clinical trial involves participants who have undergone a **renal transplant** and are at high risk of developing post-transplant diabetes. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. Participants are required to be in generally good health, allowing them to receive immunosuppressive therapy, including tacrolimus, mycophenolic acid, and steroids. The trial does not include a vulnerable population. The selection criteria focus on individuals receiving their first kidney transplant, with additional considerations for those over 50 years of age, having a body mass index greater than 30 kg/m², or a direct family history of type 2 diabetes. The sponsor has not provided information regarding the total number of participants in the study.

The clinical trial is designed to evaluate the efficacy of **vildagliptin** in preventing the onset of diabetes following a kidney transplant. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The trial is expected to last until July 2026, with participant recruitment having commenced in September 2018. The trial involves the administration of Galvus 50 mg tablets, with a maximum daily dose of 100 mg and a total treatment period of up to 8 weeks.

Participants will undergo a series of study visits, beginning with an inclusion visit to screen for eligibility. Key inclusion criteria include patients receiving their first kidney transplant and those at high risk of developing post-transplant diabetes, characterized by factors such as age over 50, a BMI greater than 30 kg/m², or a direct family history of type 2 diabetes. Follow-up visits are scheduled at 3, 6, and 12 months post-transplant to monitor primary and secondary endpoints, including the proportion of diabetic patients one year after transplantation, glycated hemoglobin levels, and various laboratory tests. The end-of-study visit will assess the long-term outcomes and overall health-related quality of life using the ReTRANSQOL questionnaire.

Participant involvement is expected to last for approximately one year, with conditions for early termination including the inability to adhere to the study protocol or the occurrence of significant adverse events. The primary endpoint is the proportion of patients developing diabetes one year post-transplant, defined by the need for diabetic treatment, fasting glucose levels above 7 mmol/l, or an abnormal oral glucose tolerance test. Secondary endpoints include the assessment of glycated hemoglobin, laboratory parameters, and the incidence of acute rejection, infection, graft loss, and patient death. The study also evaluates the cost of care and treatment up to one year after transplantation.

The clinical trial involves the administration of **Galvus 50 mg tablets**, which contain the active substance **vildagliptin**. Vildagliptin is a chemical compound, also known by its synonyms LAF237 and LAF-237. The pharmaceutical form of the medication is a tablet, and it is administered orally. The maximum daily dose of vildagliptin is 100 mg, with a total maximum dose of 5600 mg over the course of the treatment. The treatment period is limited to a maximum of 8 weeks. The medication is manufactured by Novartis Europharm Limited and is identified by the marketing authorization number EU/1/07/414/001. The ATC code for vildagliptin is A10BH02.

In this clinical trial, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The primary objective of the trial is to evaluate the efficacy of a short-term treatment with vildagliptin in preventing the onset of post-transplant diabetes one year after kidney transplantation. Participant compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the prescribed regimen.

Efficacy in this clinical trial will be assessed through both primary and secondary endpoints. The primary endpoint is the proportion of patients developing **post-transplant diabetes** one year after kidney transplantation. This is defined by the presence of one or more of the following conditions: patients receiving diabetic treatment, fasting glucose levels above 7 mmol/l, or an abnormal oral glucose tolerance test (OGTT).

Secondary endpoints include the measurement of glycated hemoglobin (HbA1c) at 3, 6, and 12 months post-transplantation. Additionally, laboratory tests such as creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, and blood count will be conducted at the same intervals. The occurrence of acute rejection, infection, graft loss, and patient death will also be monitored at 3, 6, and 12 months. Health-related quality of life will be evaluated using the ReTRANSQOL questionnaire at 8 days, 3 months, 6 months, and 12 months post-transplantation, compared to baseline. Furthermore, the cost of care and treatment will be assessed up to one year after transplantation.