Abstract:
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.
