Pharmacodynamics and pharmacokinetics of extended‐release metformin in patients with type 2 diabetes and chronic kidney disease stage 3B

Whereas the immediate-release (IR) formulation of metformin has to be taken two or three times a day, the extended-release (XR) formulation enables once-daily administration and so might help to improve patient adherence, particularly in patients with polypharmacy.Several studies have assessed metformin XR's efficacy, safety, and pharmacokinetics (PK) in healthy people and those with type 2 diabetes (T2D).1-4 Many factors affect metformin absorption, disposition and elimination in patients with chronic kidney disease (CKD), leading to metformin accumulation. Although dose adjustment has been simulated using data from metformin XR-treated patients with various levels of kidney function,5 the pharmacodynamics (PD) and PK of metformin XR in patients with T2D and a defined CKD stage have not previously been studied. We therefore decided to comprehensively assess the efficacy, steady-state PK, and safety of three dose levels of metformin XR in people with T2D and CKD stage 3B.