Open AccessA practical guide to the interpretation of PK/PD profiles of longer-acting analogue insulins. Part one: The principles of glucose clamp studies
Author(s) -
Oppel B.W. Greeff,
Jacob John van Tonder,
K. Chinnam Naidu,
Alicia McMaster,
André van Tonder,
Rashem Mothilal
Publication year - 2018
Publication title -
south african family practice
Language(s) - English
Resource type - Journals
eISSN - 2078-6204
pISSN - 2078-6190
DOI - 10.4102/safp.v60i3.4874
Subject(s) - clamp , medicine , insulin degludec , pharmacodynamics , basal (medicine) , pharmacokinetics , insulin , glucose clamp technique , insulin glargine , plasma glucose , diabetes mellitus , basal insulin , endocrinology , pharmacology , hypoglycemia , insulin resistance , insulin sensitivity , type 2 diabetes , computer science , clamping , computer vision
Glucose clamp studies are used to determine pharmacokinetics (PK) and pharmacodynamics (PD) of analogue insulins. With the development of longer-acting basal analogue insulins, including glargine 300 (Gla-300) and insulin degludec (IDeg), results from numerous glucose clamp studies are readily available. However, interpreting PK/PD profiles in a scientifically sound manner can be a challenging feat. This is the first in a series of publications that will suggest practical tips for interpreting and comparing results from glucose clamp studies. Variations in the glucose clamp methodology, duration of clamp studies and glucose clamp targets influence the study design and results significantly. Selection of study populations, including healthy patients or patients with Type 1 or 2 diabetes mellitus, has important implications. The dose of study insulin should reflect that of the general treatment population, and ideally steady-state conditions should be used. During the study the plasma insulin concentration and glucose infusion rate describe the pharmacokinetics and pharmacodynamics of the study insulin. With these practical tips in mind, results of glucose clamp studies can be interpreted in a scientifically correct manner. The next article in this series will discuss the interpretation of PK/PD profiles using two newly developed longer-acting basal analogue insulins: Gla-300 and IDeg.