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Continuous subcutaneous insulin infusion methods with a hyaluronan degrading enzyme

A technology of hyaluronidase and hyaluronic acid, which is applied in the fields of peptide/protein components, chemical instruments and methods, medical preparations containing active ingredients, etc., can solve problems such as obesity and prolonging duration

Inactive Publication Date: 2014-06-25
HALOZYME
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Further, the doses that must be administered result in a prolonged duration of action that promotes hypoglycemia and, in many cases, obesity

Method used

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  • Continuous subcutaneous insulin infusion methods with a hyaluronan degrading enzyme
  • Continuous subcutaneous insulin infusion methods with a hyaluronan degrading enzyme
  • Continuous subcutaneous insulin infusion methods with a hyaluronan degrading enzyme

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0511] Insulin and Insulin-PH20 Preparations

[0512] A. Insulin aspart

[0513] The insulin aspart used in these studies was the commercial product insulin aspart: Novo Nordisk, (named in the U.S. insulin aspart; lot number XS60195). This product contains 100 U / mL insulin aspart, 0.1096 mg / mL zinc, 1.25 mg / mL (7 mM) disodium hydrogen phosphate dihydrate, 0.58 mg / mL (10 mM) NaCl, 16 mg / mL (170 mM) glycerol, 1.5mg / mL (0.15%) phenol and 1.72mg / mL (0.172%) m-cresol.

[0514] B. Insulin Aspart-PH20 Preparations

[0515] The drug product Aspart-PH20 is a sterile, multi-dose preserved formulation of the active pharmaceutical ingredient recombinant insulin aspart with recombinant human hyaluronidase (rHuPH20, see Examples 5-7) in a neutral pH, buffered isotonic aqueous solution . Each mL of aqueous solution contains insulin aspart (recombinant insulin aspart) 3.50mg; rHuPH20 (recombinant human hyaluronidase) 5.0ug; tromethamine (Tris base) 3.63mg; sodium chloride 2.92mg; mg;...

Embodiment 2

[0517] Pharmacokinetics (PK) and glucose dynamics of insulin aspart and PH20 formulations via continuous subcutaneous insulin infusion (CSII)

[0518] The formulation of insulin aspart with human hyaluronidase (rHuPH20) described in Example 1 (aspart-PH20) was comparable to the formulation of commercial insulin aspart when delivered by continuous subcutaneous infusion in an admitted patient setting. Compare three days of diabetes treatment. Sixteen subjects with type 1 diabetes who had been using continuous subcutaneous insulin infusion (CSII) received each study drug by CSII in random order at either of two visits. Subjects were restricted to an admitted patient setting for three days of the study.

[0519] A. Research proposal

[0520] On the afternoon of the first day (Day 1) of using the Medtronic Paradigm pump system, the subject had a new infusion set placed and the reservoir was filled with aspart-PH20 or The study design allowed for comparison of infusion device p...

Embodiment 3

[0547] Insulin aspart administration with and without PH20 pretreatment by continuous subcutaneous insulin infusion (CSII)

[0548] Delivery of a commercial insulin aspart formulation by continuous subcutaneous infusion in an admitted patient setting For three days of diabetes treatment. Initially, four subjects with type 1 diabetes already on continuous subcutaneous insulin infusion (CSII) received CSII in random order at either of two visits With or without pretreatment with 150 units (U) of rHuPH20 (prepared as described in Examples 5-7). The study was continued to include 15 subjects who completed the study protocol, and was continued further to include 17 subjects who completed the study protocol. Subjects were restricted to an admitted patient setting for three days of the study.

[0549] A. Research proposal

[0550] On the first morning, subjects had a new infusion set cannula (Medtronic Quick-set) placed and received either a sham injection or 1 mL of rHuPH20 (i...

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Abstract

Provided are methods for continuous subcutaneous insulin infusion (CSIl) that employ a hyaluronan-degrading enzyme, including a recombinant human PH20 (rHuPH20). The methods can be used to more consistently control blood glucose during the course of CSIL The methods can be used to treat subjects having diabetes or other insulin-associated disease or condition.

Description

[0001] Cross References to Related Applications [0002] Claims U.S. Provisional Application No. 61 / 628,389, filed October 27, 2011, U.S. Provisional Application No. 61 / 520,940, filed June 17, 2011, and U.S. Provisional Application No. 61, filed June 8, 2012 / 657,606, said U.S. Provisional Applications, each titled "Continuous Subcutaneous Insulin Infusion Methods With a Hyaluronan-Degrading Enzyme." [0003] This application is related to U.S. Application Serial No. 13 / 507,261, entitled "CONTINUOUS SUBCUTANEOUS INSULIN INFUSION METHODS WITH A HYALURONAN-DEGRADING ENZYME," filed on the same day herewith, which claims U.S. Provisional Application No. 61 / 628,389, U.S. Provisional Application Priority of US Provisional Application No. 61 / 657,606 and US Provisional Application No. 61 / 520,940. The respective subject matter of the above related applications is incorporated by reference in its entirety. [0004] This application is also related to Provisional Application No. 61 / 520,...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K38/47A61P7/12
CPCA61K38/47A61K38/28A61P5/50A61P7/12A61P3/10A61K38/16C07K14/47
Inventor D·E·沃恩D·B·马奇莫尔G·I·弗罗斯特
Owner HALOZYME
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