Treatment for comorbid diabetes with chronic kidney disease

Patent metadata

Field	Value
Publication number	US-9259479-B2
Application number	US-201314398144-A
Country	US
Kind code	B2
Filing date	May 2, 2013
Priority date	May 9, 2012
Publication date	Feb 16, 2016
Grant date	Feb 16, 2016

Abstract

The present invention relates to an improved method for treating diabetes wherein the improvement comprises administering a PEGylated insulin compound to a patient having moderate to severe chronic kidney disease using an effective amount of the compound.

First claim

We claim:

1. A method of treating diabetes or treating hyperglycemia in a patient having moderate to end stage chronic kidney disease, comprising administering to said patient a compound of the formula P-[(A)-(B)] wherein:
A is the A-chain of insulin lispro (SEQ ID NO:1);
B is the B-chain of insulin lispro (SEQ ID NO:2); and
P is a PEG having an average molecular weight from about 17.5 kDa to about 40 kDa, and wherein A and B are properly cross-linked, and P is attached via a covalent bond to the epsilon-amine of the lysine at position 28 of B.

2. The method of claim 1 , wherein the average molecular weight of the PEG is from about 17.5 kDa to about 30 kDa.

3. The method of claim 2 , wherein the average molecular weight of the PEG is from about 17.5 kDa to about 25 kDa.

4. The method of claim 3 wherein the average molecular weight of the PEG is about 20 kDa.

5. The method of claim 1 wherein the compound is

wherein the average n is 406 to 497.

6. The method of claim 5 wherein the average n is 450 to 454.

7. The method of claim 6 , wherein the patient's creatinine clearance is less than 60 mL/min.

8. The method of claim 7 , wherein the patient's creatinine clearance is 30 to 59 mL/min.

9. The method of claim 7 wherein the patient's creatinine clearance is 15 to 29 mL/min.

10. The method of claim 7 , wherein the patient requires dialysis.

11. The method of claim 7 , wherein the diabetes is type 1 diabetes.

12. The method of claim 7 , wherein the diabetes is type 2 diabetes.

13. The method of claim 6 , wherein the method treats insulin-induced edema.

Assignees

• Lilly Co Eli

Inventors

• Sinha Vikram Paritosh
• Prince Melvin Jay
• Beals John Michael

Classifications

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61K38/28

  Insulins · CPC title

• A61K38/22 Primary

  Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35) · CPC title

• A61P13/12

  of the kidneys · CPC title

• A61K47/60

  the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol · CPC title