In short
Clinical trials investigating Vildagliptin are studying how it performs in specific patient groups, including people after kidney transplant and people with type 2 diabetes. These studies look at outcomes such as blood sugar control, prevention of new diabetes, and treatment success in tailored care plans.
Key points
- Clinical trials investigating Vildagliptin focus on two main areas: preventing new diabetes after kidney transplant and improving blood sugar control in people with type 2 diabetes. The trial data include both Phase 2 and Phase 3 studies. One study looks at whether short-term treatment after transplant can reduce diabetes one year later. Another study examines whether genetics-guided treatment can improve HbA1c results in adults with type 2 diabetes. A completed Phase 2 trial also included Vildagliptin in a study of blood sugar problems during treatment for advanced breast cancer.
Clinical trial overview
The trial data show that Vildagliptin is being studied in interventional clinical trials, which means researchers give a treatment and measure the results. The listed studies are in Phase 2 and Phase 3, which are stages used to test how well a treatment works in people and to collect more safety and outcome data.
Kidney transplant study
The PRODIG study, NCT02849899, is a Phase 3 trial in people after renal transplant, which means kidney transplant. It is authorised and plans to enroll 186 participants.
This study is testing whether a short-term course of Vildagliptin in the early post-transplant period can prevent new onset diabetes after transplantation, meaning diabetes that starts after the transplant. The main result is the proportion of patients who have diabetes 1 year after transplantation, based on diabetes treatment use, fasting glucose above 7 mmol/L, or an abnormal oral glucose tolerance test (OGTT).
Type 2 diabetes studies
One authorised Phase 3 study, 2025-520686-46-00, is in adults with Type 2 Diabetes Mellitus and plans to enroll 504 participants. It is studying whether treatment guided by genetics, called pharmacogenetic-guided treatment, works better than optimized standard treatment for people whose diabetes is not well controlled.
In this study, Vildagliptin appears among the treatment options used in the trial plan. The main endpoint is the proportion of patients who reach HbA1c ≤7% at Week 24 in the experimental arm compared with the control arm.
Another large Phase 3 study, NCT05433584, is also in adults with Type 2 Diabetes and has an enrollment of 781 participants. Vildagliptin is listed among many treatment options in this study, which compares tirzepatide with intensified conventional care. The main endpoint is change from baseline in HbA1c, a blood test that shows average blood sugar over time.
Other trial use
A completed Phase 2 study, 2024-511295-33-00, looked at people with advanced breast cancer treated with alpelisib plus endocrine therapy. Vildagliptin was listed among the trial treatments, along with other medicines used in the study.
This trial focused on hyperglycemia, which means high blood sugar, during the first 8 weeks of alpelisib treatment. One main endpoint was the rate of grade 3-4 hyperglycemia in cohorts A and B, and another was permanent discontinuation of alpelisib due to related adverse events in cohort C.
Main endpoints and what they mean
Clinical trials use endpoints, which are the main results they want to measure.
- Diabetes prevention after transplant: the study checks how many patients have diabetes 1 year after kidney transplantation.
- HbA1c target: the study checks how many people reach HbA1c ≤7% at Week 24.
- Change in HbA1c: the study measures how blood sugar control changes from the start of the study to later time points.
- Hyperglycemia during cancer treatment: the study measures how often severe high blood sugar happens in the first 8 weeks.
Who the studies are for
The trial data show that Vildagliptin is being studied in different patient groups, not just one disease area.
- People after kidney transplant, where the study asks if early treatment can lower later diabetes risk.
- Adults with type 2 diabetes, where the study looks at better blood sugar control with tailored treatment.
- People in a cancer treatment setting, where the study examined blood sugar problems during alpelisib therapy.