Abstract
Type 2 diabetes is a major public health concern. We have previously shown that initiation of glucoselowering treatment leads to altered drug efficacy. To further elucidate this surprising but potentially impactful finding, we propose to assess the effect of glucose on activity of important drug-metabolizing enzymes in a clinical pharmacokinetic study. A drug cocktail (assessing drug-metabolizing enzyme activity) will be administered to 19 patients with type 2 diabetes before and after initiation of the glucose-lowering drug metformin. This will uncover whether lowering of glucose causes altered drug metabolism in patients with type 2 diabetes. This study is part of a larger research plan including observational studies and in vitro hepatocyte studies. This translational bench to bedside approach will assess the putative link between plasma glucose and drug metabolism and the underlying mechanism. The knowledge obtained in these studies will help guide clinical decisions for managing comedication when initiating glucose-lowering treatment for patients with type 2 diabetes and provide a deeper understand of interindividual variability of drug metabolism, which is known to vary substantially.
Formål
We have previously shown that initiation of glucose-lowering treatment leads to altered drug efficacy. To further elucidate this surprising but potentially impactful finding, we will assess the metabolic activity in a clinical pharmacokinetic study in patients with type 2 diabetes. To establish the clinical effect of this we will assess the impact of initiating glucose-lowering treatment on the efficacy on concomitant medication among patients with type 2 diabetes in a register-based study.
Studiepopulation
The study subjects are patients with type 2 diabetes, diagnosed within the past 2 years, with no previous antidiabetic treatment.
Artikler
Finansiering
Immunovia AB
DD2 er ledet af Steno Diabetes Centrene
