A practical guide to the interpretation of PK/PD profiles of longer-acting analogue insulins. Part two: Insulin degludec vs. insulin glargine U300

  • Oppel BW Greeff University of Pretoria
  • Jacob John Van Tonder Triclinium Clinical Development (Pty) Ltd
  • Kershlin Naidu University of the Witwatersrand
  • Alicia McMaster Sanofi-Aventis South Africa (Pty) Ltd
  • Alet Van Tonder Sanofi-Aventis South Africa (Pty) Ltd
  • Rashem Mothilal Sanofi-Aventis South Africa (Pty) Ltd
Keywords: analogue insulins, glucose clamp, time–action profile, pharmacokinetics, pharmacodynamics

Abstract

Glucose clamp studies form an integral part of the early development of insulin therapies. Data generated in these studies are used to establish pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the agents, but methodological differences confound comparison of results from different glucose clamp studies. The first part of this series on glucose clamp studies discussed practical tips for the interpretation of glucose clamp studies. The second part of the series compares the PK/PD profiles of longer-acting basal analogue insulins, insulin degludec (IDeg) and insulin glargine U300 (Gla-300). The patient populations for glucose clamp studies with these analogue insulins differ, and therefore direct comparison of the data is not always possible. The maximum duration of action of IDeg is reported as 42 h and that of Gla-300 as 36 h, translating to 24 h coverage. The plasma insulin concentration of IDeg is 56 times that of Gla-300. Results from phase III clinical trials for these analogue insulins confirm the predictability and low within-subject variability observed in glucose clamp studies. Insight into the PK/PD profiles of longeracting basal analogue insulins allows the treating physician to utilise these characteristics to optimise the treatment of their patients with diabetes. (Full text available online at www.medpharm.tandfonline.com/oemd) Journal of Endocrinology, Metabolism and Diabetes of South Africa 2018; DOI: 10.1080/16089677.2017.1407097

Author Biographies

Oppel BW Greeff, University of Pretoria
Department of Pharmacology University of Pretoria Pretoria
Jacob John Van Tonder, Triclinium Clinical Development (Pty) Ltd
Triclinium Clinical Development (Pty) Ltd Centurion
Kershlin Naidu, University of the Witwatersrand
Department of Internal Medicine Chris Hani Baragwanath Academic Hospital University of the Witwatersrand Johannesburg
Alicia McMaster, Sanofi-Aventis South Africa (Pty) Ltd
Sanofi-Aventis South Africa (Pty) Ltd Midrand
Alet Van Tonder, Sanofi-Aventis South Africa (Pty) Ltd
Sanofi-Aventis South Africa (Pty) Ltd Midrand
Rashem Mothilal, Sanofi-Aventis South Africa (Pty) Ltd
Sanofi-Aventis South Africa (Pty) Ltd Midrand
Published
2018-08-03
Section
Review Articles