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Review

Premix insulins in type 1 diabetes: the coming of degludec/aspart

Pages 341-348 | Received 30 Mar 2018, Accepted 18 Feb 2019, Published online: 18 Mar 2019

References

  • Rosenfeld L. Insulin: discovery and controversy. Clin Chem. 2002;48(12):2270–2288.
  • Hagedorn HC, Jensen BN, Krarup NB, et al. Protamine insulinate JAMA. 1936;106(3):177–180.
  • Hallas-Moller K, Peterson K, Schlitchkrull J. Crystalline amorphous insulin-zinc compounds with prolonged action. Science. 1952;116:394–396.
  • Hallas-Moller K, Jersild M, Petersen K, et al. The lente insulins, insulin-zinc suspensions. Dan Med Bull. 1954;1:132–142.
  • Olsson PO, Hans A, Henning VS. Miscibility of human semisynthetic regular and lente insulin and human biosynthetic regular and NPH insulin. Diabetes Care. 1987;10:473–477.
  • Krayenbuhl C, Rosenberg T. Crystalline protamine insulin. Rep Steno Mem Hosp Nord Insulinlab. 1946;1:60–73.
  • Davidson MB. Insulin therapy: A personal approach. Clin Diabetes. 2015;33:123–135.
  • Sailer D, Ludwig T, Kolb S. Comparison of the activity profiles of two fixed combinations of regular/NPH human insulin (recombinant DNA) of different compositions with a fixed regular/NPH porcine insulin combination (PPI) in insulin-dependent diabetic individuals. Diabetes Care. 1982;5(Suppl 2):43–52.
  • Galloway JA, Root MA, Bergstrom R, et al. Clinical pharmacologic studies with human insulin (recombinant DNA). Diabetes Care. 1982;5(Suppl 2):13–22.
  • Botterman P, Gyaram H, Wahl K, et al. Pharmacokinetics of biosynthetic human insulin and characteristics of its effect. Diabetes Care. 1981;168–169.
  • Bottermann P, Gyaram H, Wahl K, et al. Insulin concentrations and time-action profiles of three different intermediate-acting insulin preparations in nondiabetic volunteers under glucose-controlled glucose infusion technique. Diabetes Care. 1982;5(Suppl 2):43–52.
  • Weinges K, Ehrhardt M, Nell G, et al. Pharmacodynamics of human insulin (recombinant DNA)–regular, NPH, and mixtures–obtained by the Gerritzen method in healthy volunteers. Diabetes Care. 1982;5(Suppl 2):43–52.
  • Phillips M, Simpson RW, Holman RR, et al. A simple and rational twice daily insulin regime. Distinction between basal and meal insulin requirements. Q J Med. 1979;48:493–506.
  • Bell DSH, Clements RS, Perentesis G, et al. Dosage accuracy of self-mixed vs premixed insulin. Arch Intern Med. 1991;151:2265–2269.
  • Oakley N, Mather H, Hadley L, et al. Twice-daily insulin regimens in management of severe diabetes. J R Soc Med. 1981;74:363–367.
  • Howey DC, Bowsher RR, Brunelle RL, et al. [Lys(B28), Pro(B29)]-human insulin: effect of injection time on postprandial glycemia. Clin Pharmacol Ther. 1995;58:459–469.
  • Janssen MM, Casteleijn S, Devillé W, et al. Nighttime insulin kinetics and glycemic control in type 1 diabetes patients following administration of an intermediate-acting lispro preparation. Diabetes Care. 1997;20:1870–1873.
  • Heise T, Weyer C, Serwas A, et al. Time-action profiles of novel premixed preparations of insulin lispro and NPL insulin. Diabetes Care. 1998;21:800–803.
  • Janssen MM, Snoek FJ, Masurel N, et al. Optimized basal-bolus therapy using a fixed mixture of 75% lispro and 25% NPL insulin in type 1 diabetes patients: no favorable effects on glycemic control, physiological responses to hypoglycemia, well-being, or treatment satisfaction. Diabetes Care. 2000;23:629–633.
  • Kang S, Creagh FM, Peters JR, et al. Comparison of subcutaneous soluble human insulin and insulin analogues (AspB9, GluB27; AspB10; AspB28) on meal-related plasma glucose excursions in type I diabetic subjects. Diabetes Care. 1991;14:571–577.
  • Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997;20:1612–1614.
  • Bolli GB, Owens DR. Insulin Glargine. Lancet. 2000;356(9228):443–445.
  • Owens DR, Coates PA, Luzio SD, et al. Pharmacokinetics of 125I-labeled insulin Glargine (HOE 901) in healthy men: comparison with NPH insulin and the influence of different subcutaneous injection sites. Diabetes Care. 2000;23:813–819.
  • Lepore M, Pampanelli S, Fanelli C, et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes. 2000;49:2142–2148.
  • Scholtz HE, Pretorius SG, Wessels DH, et al. Pharmacokinetic and glucodynamic variability: assessment of insulin Glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique. Diabetologia. 2005;48:1988–1995.
  • Fulcher GR, Gilbert RE, Yue DK. Glargine is superior to neutral protamine Hagedorn for improving glycated haemoglobin and fasting blood glucose levels during intensive insulin therapy. Intern Med J. 2005;35:536–542.
  • Herwig J, Scholl-Schilling G, Bohles H. Glycaemic control and hypoglycaemia in children, adolescents and young adults with unstable type 1 diabetes mellitus treated with insulin Glargine or intermediate-acting insulin. J Pediatr Endocrinol Metab. 2007;20:517–525.
  • Rossetti P, Pampanelli S, Fanelli C, et al. Intensive replacement of basal insulin in patients with type 1 diabetes given rapid-acting insulin analog at mealtime: a 3-month comparison between administration of NPH insulin four times daily and Glargine insulin at dinner or bedtime. Diabetes Care. 2003;26:1490–1496.
  • Testa MA, Gill J, Su M, et al. Comparative effectiveness of basal-bolus versus premix analog insulin on glycemic variability and patient-centered outcomes during insulin intensification in type 1 and type 2 diabetes: a randomized, controlled, crossover trial. J Clin Endocrinol Metab. 2012;97:3504–3514.
  • Sharplin P, Gordon J, Peters JR, et al. Switching from premixed insulin to glargine-based insulin regimen improves glycaemic control in patients with type 1 or type 2 diabetes: a retrospective primary-care-based analysis. Cardiovasc Diabetol. 2009;16(8):9.
  • Schmidt S, Vistisen D, Almdal T, et al. Exploring factors influencing HbA1c and psychosocial outcomes in people with type 1 diabetes after training in advanced carbohydrate counting. Diabetes Res Clin Pract. 2017;130:61–66.
  • Tascini G, Berioli MG, Cerquiglini L, et al. Carbohydrate counting in children and adolescents with Type 1 diabetes. Nutrients. 2018;10:E1095.
  • Kramer G, Kuniss N, Kloos C, et al. Principles and frequency of self-adjustment of insulin dose in people with diabetes mellitus type 1 and correlation with markers of metabolic control. Diabetes Res Clin Pract. 2016;116:299–305.
  • Kramer G, Kuniss N, Jörgens V, et al. Prospective analysis of principles and frequency of self-adjustment of insulin dose in people with diabetes type 1 before and after participation in a diabetes treatment and teaching programme. Diabetes Res Clin Pract. 2016;119:65–70.
  • Davidson PC, Hebblewhite HR, Steed RD, et al. Analysis of guidelines for basal-bolus insulin dosing: basal insulin, correction factor, and carbohydrate-to-insulin ratio. Endocr Pract. 2008;14:1095–1101.
  • Rendell M. Technosphere inhaled insulin (Afrezza). Drugs Today (Barc). 2014;50:813–827.
  • Dailey G, Ahmad A, Polsky S, et al. A novel option for prandial insulin therapy: inhaled insulin. Postgrad Med. 2016;128:839–847.
  • Heinemann L, Baughman R, Boss A, et al. Pharmacokinetic and pharmacodynamic properties of a novel inhaled insulin. J Diabetes Sci Technol. 2017;11:148–156.
  • Havelund S, Plum A, Ribel U, et al. The mechanism of protraction of insulin detemir, a long-acting, acylated analog of human insulin. Pharm Res. 2004;21:1498–1504.
  • Plank J, Bodenlenz M, Sinner F, et al. A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabetes Care. 2005;28:1107–1112.
  • Porcellati F, Rossetti P, Busciantella NR, et al. Comparison of pharmacokinetics and dynamics of the long-acting insulin analogs Glargine and detemir at steady state in type 1 diabetes: a double-blind, randomized, crossover study. Diabetes Care. 2007;30:2447–2452.
  • Kolendorf K, Ross GP, Pavlic-Renar I, et al. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet.Med.2006;23:729–735.
  • 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;29:2104–2114.
  • Steensgaard DB, Schluckebier G, Strauss HM, et al. Ligand-controlled assembly of hexamers, dihexamers, and linear multihexamer structures by the engineered acylated insulin degludec. Biochemistry. 2013;52:295–309.
  • Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014;53:787–800.
  • Heise T, Hövelmann U, Nosek L, et al. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol. 2015;11:1193–1201.
  • Heise T, Nosek L, Bøttcher SG, et 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.
  • 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.
  • Havelund S, Ribel U, Hubálek F, et al. Investigation of the physico-chemical properties that enable co-formulation of basal insulin Degludec with fast-acting insulin Aspart. Pharm Res. 2015;32:2250–2258.
  • Kalra S. Insulin Degludec Aspart: the first co-formulation of insulin analogues. Diabetes Ther. 2014;5:65–72.
  • Biester T, Danne T, Bläsig S, et al. Pharmacokinetic and prandial pharmacodynamic properties of insulin degludec/insulin aspart in children, adolescents, and adults with type 1 diabetes. Pediatr Diabetes. 2016 Dec;17(8):642–649.
  • Heller S, Buse J, Fisher M, et al. Insulin degludec, an ultra-longacting 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(9825):1489–1497.
  • Mathieu C, Hollander P, Miranda-Palma B, et al. Efficacy and safety of insulin Degludec in a flexible dosing regimen vs insulin Glargine in patients with Type 1 Diabetes (BEGIN: Flex T1): A 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab. 2013;98:1154–1162.
  • Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin Glargine U100 on hypoglycemia in patients with type 2 diabetes: the SWITCH 2 randomized clinical trial. JAMA. 2017;318:45–56.
  • Lane W, Bailey TS, Gerety G, et al. Effect of insulin degludec vs insulin Glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA. 2017 4;318:33–44.
  • Hirsch IB, Bode B, Courreges JP, et al. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012;35:2174–2181.
  • Zinman B, Fulcher G, Rao PV, et al. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label,phase 2 trial. Lancet. 2011;377(9769):924–931.
  • Zinman B, DeVries JH, Bode B, et al. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013;1:123–131.
  • Monnier L, Owens DR, Bolli GB. The new long-acting insulin glargine U300 achieves an early steady state with low risk of accumulation. Diabetes Metab. 2016;42:77–79.
  • Sutton G, Minguet J, Ferrero C, et al. U300, a novel long-acting insulin formulation. Expert Opin Biol Ther. 2014;14:1849–1860.
  • 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.

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