Table of Contents
- Clinical trial overview
- Kidney transplant study
- Type 2 diabetes studies
- Other trial use
- Main endpoints and what they mean
- Who the studies are for
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.[1] 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.[1][2]
Kidney transplant study
The PRODIG study, NCT02849899, is a Phase 3 trial in people after renal transplant, which means kidney transplant.[1] It is authorised and plans to enroll 186 participants.[1]
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.[1] 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).[1]
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.[2] 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.[2]
In this study, Vildagliptin appears among the treatment options used in the trial plan.[2] The main endpoint is the proportion of patients who reach HbA1c ≤7% at Week 24 in the experimental arm compared with the control arm.[2]
Another large Phase 3 study, NCT05433584, is also in adults with Type 2 Diabetes and has an enrollment of 781 participants.[4] Vildagliptin is listed among many treatment options in this study, which compares tirzepatide with intensified conventional care.[4] The main endpoint is change from baseline in HbA1c, a blood test that shows average blood sugar over time.[4]
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.[3] Vildagliptin was listed among the trial treatments, along with other medicines used in the study.[3]
This trial focused on hyperglycemia, which means high blood sugar, during the first 8 weeks of alpelisib treatment.[3] 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.[3]
Main endpoints and what they mean
Clinical trials use endpoints, which are the main results they want to measure.[1][2][3][4]
Diabetes prevention after transplant: the study checks how many patients have diabetes 1 year after kidney transplantation.[1]
HbA1c target: the study checks how many people reach HbA1c ≤7% at Week 24.[2]
Change in HbA1c: the study measures how blood sugar control changes from the start of the study to later time points.[4]
Hyperglycemia during cancer treatment: the study measures how often severe high blood sugar happens in the first 8 weeks.[3]
Who the studies are for
The trial data show that Vildagliptin is being studied in different patient groups, not just one disease area.[1][2][3][4]
People after kidney transplant, where the study asks if early treatment can lower later diabetes risk.[1]
Adults with type 2 diabetes, where the study looks at better blood sugar control with tailored treatment.[2]
People in a cancer treatment setting, where the study examined blood sugar problems during alpelisib therapy.[3]
