Use of recombinant human hyaluronidase to accelerate rapid insulin analogue absorption: Experience with subcutaneous injection and continuous infusion

Endocrine Practice

Volumn 17, Issue 6, 2011, Pages 914-921

  Vaughn, Daniel ^a   Muchmore, Douglas ^a  

^a Halozyme Therapeutics Inc ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN; INSULIN ASPART; INSULIN LISPRO; RECOMBINANT HYALURONIDASE;

ARTICLE; CONTINUOUS INFUSION; DIABETIC PATIENT; DISPERSION; DRUG ABSORPTION; DRUG EXPOSURE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; NON INSULIN DEPENDENT DIABETES MELLITUS; POSTPRANDIAL STATE; RANDOMIZED CONTROLLED TRIAL (TOPIC); TEST MEAL;

EID: 84855831064     PISSN: 1530891X     EISSN: 19342403     Source Type: Journal    
DOI: 10.4158/EP11297.RA     Document Type: Article

References (49)

1. Aukland K, Reed RK. Interstitial-lymphatic mechanisms in the control of extracellular fuid volume. Physiol Rev. 1993;73:1-78. (Pubitemid 23065433)
2. Muchmore DB, Vaughn DE. Review of the mechanism of action and clinical effcacy of recombinant human hyal-uronidase coadministration with current prandial insulin formulations. J Diabetes Sci Technol. 2010;4:419-428.
3. Søeborg T, Rasmussen CH, Mosekilde E, Colding-Jørgensen M. Absorption kinetics of insulin after subcuta-neous administration. Eur J Pharm Sci. 2009;36:78-90.
4. Supersaxo A, Hein WR, Steffen H. Effect of molecular weight on the lymphatic absorption of water-soluble com-pounds following subcutaneous administration. Pharm Res. 1990;7:167-169. (Pubitemid 20208069)
5. Becker RH, Frick AD. Clinical pharmacokinetics and phar-macodynamics of insulin glulisine. Clin Pharmacokinet. 2008;47:7-20. (Pubitemid 350260885)
6. Lindholm A, Jacobsen LV. Clinical pharmacokinetics and pharmacodynamics of insulin aspart. Clin Pharmacokinet. 2001;40:641-659. (Pubitemid 32954988)
7. Howey DC, Bowsher RR, Brunelle RL, et al. [Lys(B28), Pro(B29)]-human insulin: effect of injection time on post-prandial glycemia. Clin Pharmacol Ther. 1995;58:459-469.
8. DeWitt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientifc review. JAMA. 2003;289:2254-2264. (Pubitemid 37430194)
9. Heinemann L., Variability of insulin absorption and insulin action Diabetes Technol Ther. 2002 4 673-682.
10. Guerci B, Sauvanet JP. Subcutaneous insulin: pharma-cokinetic variability and glycemic variability Diabetes Metab. 2005;31(4, pt 2):4S7-4S24. (Pubitemid 41379375)
11. National Research Council, National Academy of Science. Drug Effcacy Study Implementation (DESI) review: hyaluronidase injection. US Food and Drug Administration. Fed Reg. 1970;35:14800-14801.
12. Yocum RC, Kennard D, Heiner LS. Assessment and implication of the allergic sensitivity to a single dose of recombinant human hyaluronidase injection: a double-blind, placebo-controlled clinical trial. J Infus Nurs. 2007; 30:293-299. (Pubitemid 47585290)
13. Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fuid administration. Expert Opin Drug Deliv. 2007;4:427-440. (Pubitemid 47249140)
14. Bookbinder LH, Hofer A, Haller MF, et al. A recombi-nant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006;114:230-241. (Pubitemid 44291844)
15. Vaughn DE, Yocum RC, Muchmore DB, et al. Accelerated pharmacokinetics and glucodynamics of pran-dial insulins injected with recombinant human hyaluroni-dase. Diabetes Technol Ther. 2009;11:345-352.
16. Morrow L,Muchmore DB,Ludington EA,Vaughn DE,Hompesch M Reduction in intrasubject variability in the pharmacokinetic response to insulin after subcutaneous co-administration with recombinant human hyaluronidase in healthy volunteers [published online ahead of print June 29 [2011] Diabetes Technol Ther. PMID: 21714645.
17. Muchmore DB, Hompesch M, Morrow L, Vaughn DE. Human hyaluronidase coinjection consistently accelerates prandial insulin pharmacokinetics (PK) and glucodynamics (GD) across studies and populations [abstract]. Diabetes. 2011;60(suppl 1):A264.
18. Vaughn DE, Gee L, Ludington E, Muchmore DB. Improved dose proportionality of insulin lispro injected with hyaluronidase [abstract]. J Diabetes Sci Technol. 2010;4:A176.
19. Morrow L, Muchmore DB, Hompesch M, Ludington E, Vaughn DE. Human hyaluronidase coinjection accelerates insulin pharmacokinetics and glucodynamics of 3 rapid insulin analogs [abstract]. Diabetes. 2010; 59(suppl 1) A94.
20. Hompesch M, Muchmore DB, Morrow L, Vaughn DE. Accelerated insulin pharmacokinetics and improved postprandial glycemic control in patients with type 1 dia-betes after coadministration of prandial insulins with hyal-uronidase. Diabetes Care. 2011;34:666-668.
21. Hompesch M, Muchmore DB, Morrow L, Ludington E, Vaughn DE. Improved postprandial glycemic control in patients with type 2 diabetes from subcutaneous injec-tion of insulin lispro with hyaluronidase. Diabetes Technol Ther. 2012. In press.
22. Buse JB, Garg SK, Skyler JS, Vaughn DE, Muchmore DB. Comparison of human hyaluronidase + recombinant human insulin (RHI) vs. insulin lispro in a basal-bolus regi-men in patients with type 1 diabetes (T1DM) [abstract]. Diabetes. 2011;60(suppl 1):A18.
23. Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010;1:CD005103.
24. Swan KL, Dziura JD, Steil GM, et al. Effect of age of infusion site and type of rapid-acting analog on pharmaco-dynamic parameters of insulin boluses in youth with type 1 diabetes receiving insulin pump therapy Diabetes Care. 2009;32:240-244.
25. Clausen TS, Kaastrup P, Stallknecht B. Effect of insulin catheter wear-time on subcutaneous adipose tissue blood fow and insulin absorption in humans. Diabetes Technol Ther. 2009;9:575-580.
26. Alsted TS. Device-Induced Subcutaneous Trauma [PhD thesis]. Copenhagen, Denmark: University of Copenhagen, 2010.
27. Clausen TS, Kaastrup P, Stallknecht B. Proinfammatory tissue response and recovery of adipokines during 4 days of subcutaneous large-pore microdialysis. J Pharmacol Toxicol Methods. 2009;60:281-287.
28. Muchmore DB, Morrow L, Hompesch M, Vaughn DE. Recombinant human hyaluronidase (rHuPH20) accelerates rapid insulin analog pharmacokinetics (PK) when delivered either by subcutaneous injection or by continuous subcuta-neous insulin infusion (CSII). In: American Association of Clinical Endocrinologists Annual Meeting Syllabus, 2011.
29. Morrow L, Muchmore D, Hompesch M, Jiang P, Jadin L, Vaughn D. Addition of human hyaluronidase to rapid analog insulin reduces the absolute variability of early insulin absorption across infusion set life. Diabetes. 2011; 60(suppl 1):LB8. e144-e148
30. Chong WH, Molinolo AA, Chen CC, Collins MT. Tumor-induced osteomalacia. Endocr Relat Cancer. 2011;18: R53-R77.
31. Jan de Beur SM. Tumor-induced osteomalacia. JAMA. 2005;294:1260-1267. (Pubitemid 41352115)
32. Tartaglia F, Minisola S, Sgueglia M, et al. Tumor-induced hypophosphatemic osteomalacia associated with tertiary hyperparathyroidism: a case report. G Chir. 2006;27:9-13.
33. Tournis S, Samdanis V, Economopoulos D, Giannikou P, Lyritis GP. Autonomous hyperparathyroidism follow-ing long-term phosphate treatment for tumor-induced osteomalacia. Case report and review of the literature. The Endocrinologist. 2007;17:263-266. (Pubitemid 47508890)
34. Cheng CL, Ma J, Wu PC, Mason RS, Posen S. Osteomalacia secondary to osteosarcoma. A case report. J Bone Joint Surg Am. 1989;71:288-292. (Pubitemid 19091413)
35. Schussler GC, Verso M, Nemoto T. Phosphaturia in hypercalcaemic breast cancer patients. J Clin Endocrinol Metab. 1972;35:497-504.
36. Haviv YS, Silver J. Late onset oncogenic osteomalacia-associated with neurofbromatosis type II. Clin Nephrol. 2000;54:429-430.
37. Lever EG, Pettingale KW. Albright's syndrome associ-ated with a soft-tissue myxoma and hypophosphataemic osteomalacia. Report of a case and review of the literature. J Bone Joint Surg Br. 1983;65:621-626. (Pubitemid 14231206)
38. Gattineni J, Baum M. Regulation of phosphate trans-port by fbroblast growth factor 23 (FGF23): implications for disorders of phosphate metabolism. Pediatr Nephrol. 2010;25:591-601.
39. Jan de Beur SM, Streeten EA, Civelek AC, et al. Localisation of mesenchymal tumours by somatostatin receptor imaging. Lancet. 2002;359:761-763. (Pubitemid 34215078)
40. Rhee Y, Lee JD, Shin KH, Lee HC, Huh KB, Lim SK. Oncogenic osteomalacia associated with mesenchymal tumour detected by indium-111 octreotide scintigraphy Clin Endocrinol (Oxf). 2001;54:551-554. (Pubitemid 34204193)
41. Hesse E, Moessinger E, Rosenthal H, et al. Oncogenic osteomalacia: exact tumor localization by co-registration of positron emission and computed tomography J Bone Miner Res. 2007;22:158-162. (Pubitemid 46032609)
42. Jagtap VS, Sarathi V, Lila AR, et al. Tumor-induced osteomalacia: a single center experience. Endocr Pract. 2011;17:177-184.
43. Weidner N, Santa Cruz D. Phosphaturic mesenchymal tumors. A polymorphous group causing osteomalacia or rickets. Cancer. 1987;59:1442-1454. (Pubitemid 17044999)
44. Kronenberg HM. NPT2a-the key to phosphate homeosta-sis. N Engl J Med. 2002;347:1022-1024.
45. Hernando N, Wagner C, Biber J, Murer H. Kidney kinase network regulates renal ion cotransport. J Clin Invest. 2007;117:3179-3182. (Pubitemid 350096974)
46. Farrow EG, White KE. Tumor-induced osteomalacia. Expert Rev Endocrinol Metab. 2009;4:435-442.
47. Jüppner H, Wolf M, Salusky IB. FGF-23: More than a regulator of renal phosphate handling? J Bone Miner Res. 2010;25:2091-2097.
48. Geller JL, Khosravi A, Kelly MH, Riminucci M, Adams JS, Collins MT. Cinacalcet in the management of tumor-induced osteomalacia. J Bone Miner Res. 2007;22:931-937.
49. Seufert J, Ebert K, Müller J, et al. Octreotide therapy for tumor-induced osteomalacia. N Engl J Med. 2001;345: 1883-1888. (Pubitemid 33716563)