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Super fast-acting insulin compositions

A technology of effective insulin and composition, applied in the field of super fast-acting insulin composition, which can solve problems such as obesity, prolonged action time, and hypoglycemia

Inactive Publication Date: 2011-06-01
HALOZYME
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, the doses that must be given result in a prolonged duration of action, which can cause hypoglycemia and in many cases obesity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0457] Co-administration of recombinant human PH20 (rHuPH20) and rapid-acting insulin contributes to improved pharmacokinetics and pharmacodynamics

[0458] Insulin, including insulin analogs, is administered to individuals with diabetes for the management of hyperglycemia. To more effectively replicate the normal physiological prandial insulin release observed in healthy individuals, a clinical study was conducted to determine whether co-administration of recombinant human PH20 (rHuPH20) could increase the early absorption rate and absorption of administered rapid-acting insulin quantity. Increased absorption may result in a more accelerated acting of the rapid-acting insulin and thus more closely mimic the endogenous insulin-time profile observed in healthy individuals. This may provide clinical benefits in terms of better glycemic control and reduced weight gain in diabetic individuals. The clinical study was designed to evaluate rHuPH20 when administered subcutaneously a...

Embodiment 1a

[0460] With or without co-administration of rHuPH20 R insulin and Pharmacokinetics and Pharmacodynamics of Insulin Lispro in Healthy (Non-diabetic) Individuals

[0461] A randomized, double-blind, crossover, two-stage, continuous controlled study (2-arm study) was conducted to evaluate subcutaneous administration of 20 units of insulin lispro or R insulin. Twenty-five healthy adult male subjects were enrolled in this study. In Phase 1, 12 individuals received Subcutaneous injection of insulin lispro and rHuPH20 and only A separate subcutaneous injection of insulin lispro. Injections are usually 7 days apart, with half the individuals receiving the first Insulin lispro and rHuPH20, followed by separate Insulin lispro, half of the individuals first received a separate insulin lispro, then receive Insulin lispro and rHuPH20. In Phase 2, 13 individuals received Subcutaneous injection of R insulin and rHuPH20 and only A separate subcutaneous injection of in...

Embodiment 1b

[0555] Subcutaneously administered with and without rHuPH20 insulin lispro or Pharmacokinetics and postprandial glycemic response of R insulin in patients with type 1 diabetes mellitus after eating liquid food

[0556] The efficacy of subcutaneous injection with and without rHuPH20 co-administration was evaluated insulin lispro and A study of the pharmacokinetics and postprandial glycemic response (i.e. pharmacodynamics (PD)) of R insulin in type 1 diabetic patients following a liquid diet. The trial was a single-blind (only patients blinded), single-centre, crossover, liquid-food trial (including a series of standardized liquid-food loads) in patients with type 1 diabetes mellitus, with blood samples collected 2 hours before and 8 hours after dosing. In the analysis of PK and PD parameters.

[0557] Each individual experiences a series of A dose-finding visit of insulin lispro and rHuPH20 (visits 2A-C; a total of three injections) to determine optimal glycemic contr...

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Abstract

Provided are combinations, compositions and kits containing an fast-acting insulin composition and a hyaluronan degrading enzyme composition formulated for parenteral administration. Such products can be used in methods of treating insulin- treatable diseases or conditions. Also provided are methods for administration of a fast-acting insulin and a hyaluronan degrading enzyme.

Description

[0001] Related Patent Applications [0002] This application asserts U.S. Provisional Patent Application No. 61 / 125,835, filed April 28, 2008, by Gregory Frost, Igor Bilinsky, Daniel Vaughn, and Barry Sugarman, entitled "Super Fast-Acting Insulin Compositions" and Gregory Frost, Igor Bilinsky, Daniel Vaughn Priority to U.S. Provisional Patent Application No. 61 / 127,044, filed May 9, 2008, entitled "Super Fast-Acting Insulin," by and Barry Sugarman. [0003] This application is related to the corresponding U.S. Patent Application No. 12 / 387,225 entitled "Super Fast-Acting Insulin Compositions" by Gregory Frost, Igor Bilinsky, Daniel Vaughn, and BarrySugarman, which also claims Serial Nos. 61 / 125,835 and 61 / 127,044 Priority of U.S. Provisional Patent Application No. [0004] The subject matter of each of the patent applications cited above is hereby incorporated by reference in its entirety. technical field [0005] Combinations, compositions and kits comprising a rapid-acting...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K38/47A61P5/50A61P3/10
CPCA61K38/47A61K38/28A61P3/00A61P43/00A61P5/00A61P5/48A61P5/50A61P3/10A61K2300/00
Inventor G·I·弗罗斯特I·比林斯基D·沃恩B·休格曼
Owner HALOZYME
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