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

References

• Amod A , Motala A , Levitt N , et al . The 2012 SEMDSA guideline for the management of type 2 diabetes. JEMDSA. 2012;17(1): S1–S94.
   Google Scholar
• Eliaschewitz FG , Barreto T . Concepts and clinical use of ultra-long basal insulin. Diabetology and Metabolic Syndrome. 2016;8(2): 1–8.
   PubMedGoogle Scholar
• Hilgenfeld R , Seipke G , Berchtold H , et al . The evolution of insulin glargine and its continuing contribution to diabetes care. Drugs. 2014;74: 911–27.10.1007/s40265-014-0226-4
   PubMed Web of Science ®Google Scholar
• Bolli GB , Owens DR . Insulin glargine. The Lancet. 2000;356(9228): 443–5.10.1016/S0140-6736(00)02546-0
   PubMed Web of Science ®Google Scholar
• Steinstraesser A , Schmidt R , Bergmann K , et al . Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml. Diabetes Obes Metab. 2014;16(9): 873–876.10.1111/dom.12283
   PubMed Web of Science ®Google Scholar
• Heinemann L . Time-action profiles of insulin preparations. Mainz: Kirchheim; 2004.
   Google Scholar
• Heise T , Nosek L . Bottcher SG, at al. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab. 2012;14: 944–950.10.1111/dom.2012.14.issue-10
   PubMed Web of Science ®Google Scholar
• Heise T , Hermanski L , Nosek L , et al . Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14: 859–864.10.1111/dom.2012.14.issue-9
   PubMed Web of Science ®Google Scholar
• Heise T , Hövelmann U , Nosek L , et al . Comparison of the pharmacokinetic and pharmacodynamics profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol. 2015;11(8): 1193–1201.10.1517/17425255.2015.1058779
   PubMed Web of Science ®Google Scholar
• Becker RHA , Dahmen R , Bergmann K , et al . New insulin glargine 300 units.mL−1 provides a more even activity profile and prolonged glycaemic control at steady state compared with insulin glargine 100 units.mL−1 . Diabetes Care. 2014;1–7.
   Web of Science ®Google Scholar
• Shiramoto M , Eto T , Irie S , et al . Single-dose new insulin glargine 300 U/ml provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes Metab. 2015;17: 254–60.10.1111/dom.2015.17.issue-3
   PubMed Web of Science ®Google Scholar
• Becker RHA , Nowotny I , Teichert L , et al . Low within- and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes Metab. 2015;17: 261–7.10.1111/dom.2015.17.issue-3
   PubMed Web of Science ®Google Scholar
• Swinnen SGHA , Holleman F , DeVries JH . The interpretation of glucose clamp studies of long-acting insulin analogues: from physiology to marketing and back. Diabetologia. 2008;51: 1790–5.10.1007/s00125-008-1098-5
   PubMed Web of Science ®Google Scholar
• Lepore M , Pampanelli S , Fanelli C , et al . Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analogue Glargine, NPH insulin and Ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes. 2000; 49:2142Home P. Pharmacokinetics and pharmacodynamics of biosimilar insulins: is clamp technology fit for purpose? Diabetes Care. 2015;38: 2234–36.
   PubMedGoogle Scholar
• Home P . Pharmacokinetics and pharmacodynamics of biosimilar insulins: is clamp technology fit for purpose? Diabetes Care. 2015;38: 2234–2236.10.2337/dc15-1046
   PubMed Web of Science ®Google Scholar
• Heise T , Zijlstra E , Nosek L , et al . Euglycaemic glucose clamp: what it can and cannot do, and how to do it. Diabetes Obes Metab. 2016;18(10): 962–972.10.1111/dom.2016.18.issue-10
   PubMed Web of Science ®Google Scholar
• Siraj EJ , Rubin DJ , Riddle MC , et al . Insulin dose and cardiovascular mortality in the ACCORD trial. Diabetes Care. 2015;38: 2000–8.10.2337/dc15-0598
   PubMed Web of Science ®Google Scholar
• Rave K , Bott S , Heinemann L , et al . Time-Action Profile of Inhaled Insulin in Comparison With Subcutaneously Injected Insulin Lispro and Regular Human Insulin. Diabetes Care. 2005;28: 1077–82.10.2337/diacare.28.5.1077
   PubMed Web of Science ®Google Scholar
• Bailey T , Dahmen, R , Petthus J , et al . Insulin glargine 300 U/ml (Gla-300) provides more stable and more evenly distributed steady-state PK/PD profiles compared with insulin degludec in type 1 diabetes. In: Diabetes Techology Society; 2016 10–12 November 2016, Bethesda, MD, USA.
   Google Scholar
• Kurtzhals P , Havelund S , Jonassen I , et al . Albumin binding of insulins acylated with fatty acids: characterization of the ligand-protein interaction and correlation between binding affinity and timing of the insulin effect in vivo . Biochem. J. 1995;312(3): 725–31.10.1042/bj3120725
   PubMedGoogle Scholar
• Jonassen I , Havelund S , Hoeg-Jensen T , et al . Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res. 2012;29: 2104–24.10.1007/s11095-012-0739-z
   PubMed Web of Science ®Google Scholar
• Lamos EM , Younk LM , Davis SN . Concentrated insulins: the new basal insulins. Ther Clin Risk Manag. 2016;12: 389–400.
   PubMed Web of Science ®Google Scholar
• Weyer C , Hanson RL , Tataranni PA. , et al . A high fasting plasma insulin concentration predicts type 2 diabetes independent of insulin resistance: evidence for a pathogenic role of relative hyperinsulinemia. Diabetes. 2000;49: 2094–2101.10.2337/diabetes.49.12.2094
   PubMed Web of Science ®Google Scholar
• Heller S , Buse J , Fisher M , et al . Insulin degludec, an ultra-long acting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012;379: 1489–97.10.1016/S0140-6736(12)60204-9
   PubMed Web of Science ®Google Scholar
• Garber AJ , King AB , Prato S , et al . Insulin degludec, an ultra-long acting basal insulin versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012;379: 1498–1507.10.1016/S0140-6736(12)60205-0
   PubMed Web of Science ®Google Scholar
• Zinman B , Philis-Tsimikas A , Cariou B , et al . Insulin degludec versus insulin glargine in insulin-naïve patients with type 2 diabetes: a 1-year randomised, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012;35(12): 2464–71.10.2337/dc12-1205
   PubMed Web of Science ®Google Scholar
• Riddle MC , Bolli GB , Ziemen M , et al . New insulin glargine 300 units/ml versus glargine 100 units/ml in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a 6-month randomised controlled trial (EDITION 1). Diabetes Care. 2014;37: 2755–62.10.2337/dc14-0991
   PubMed Web of Science ®Google Scholar
• Yki-Järvinen H , Bergenstal R , Ziemen M , et al . New insulin glargine 300 units/ml versus glargine 100 units/ml in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycaemia in a 6-month randomised controlled trial (EDITION 2). Diabetes Care. 2014;37: 3235–43.10.2337/dc14-0990
   PubMed Web of Science ®Google Scholar
• Home PD , Bergenstal RM , Bolli GB , et al . New insulin glargine 300 units/ml versus glargine 100 units/ml in people with type 1 diabetes: a randomised, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care. 2014;7(12): 3235–43.
   Google Scholar