US2006199763A1PendingUtilityA1

Derivatives of GLP-1 analogs

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Assignee: KNUDSEN LISELOTTE BPriority: Aug 30, 1996Filed: Dec 9, 2004Published: Sep 7, 2006
Est. expiryAug 30, 2016(expired)· nominal 20-yr term from priority
Inventors:Liselotte Bjerre KnudsenPer Olaf HuusfeldtPer Franklin NielsenNiels KaarsholmHelle Birk OlsenSoren BjornFreddy Zimmerdahl PedersenKjeld Madsen
A61K 47/24C11D 3/168A61K 31/426A61K 38/2264C11D 3/0063A61K 31/4439A61K 38/28A61K 38/26C07K 14/605A61K 45/06
64
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Claims

Abstract

The present invention relates to a pharmaceutical composition comprising a GLP-1 derivative having a lipophilic substituent; and a surfactant.

Claims

exact text as granted — not AI-modified
1 . A method of treating non-insulin dependent diabetes mellitus (NIDDM) comprising coadministering a GLP-1 molecule or an analog or derivative thereof and a thiazolidinedione compound.  
     
     
         2 . The method of  claim 1 , wherein the thiazolidinedione is troglitazone.  
     
     
         3 . The method of  claim 1 , wherein the thiazolidinedione is ciglitazone.  
     
     
         4 . The method of  claim 1  wherein the GLP-1 molecule is GLP-1(7-36) or GLP-1(7-37).  
     
     
         5 . The method of  claim 1  wherein the GLP-1 molecule is an analog or derivative of His 7 -Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Lys-Gly-Arg 36 -X, where X is NH 2  or Gly.  
     
     
         6 . The method of  claim 5  wherein the GLP-1 molecule to be administered is provided in a concentration of at least about 2 mg/ml.  
     
     
         7 . The method of  claim 5  wherein the GLP-1 molecule to be administered is provided in a concentration of at least about 5 mg/ml.  
     
     
         8 . The method of  claim 5  wherein the GLP-1 molecule is to be administered is provided in a concentration of at least about 10 mg/ml.  
     
     
         9 . The method of  claim 5  wherein the GLP-1 molecule to be administered is provided in a concentration of at least about 2 to about 100 mg/ml.  
     
     
         10 . The method of  claim 5  wherein the GLP-1 molecule to be administered is provided in a concentration of at least about 5 to about 100 mg/ml.  
     
     
         11 . The method of  claim 5  wherein the GLP-1 molecule to be administered is provided in a concentration of at least about 10 to about 100 mg/ml.  
     
     
         12 . The method of  claim 5 , wherein the GLP-1 molecule is a GLP-1 derivative.  
     
     
         13 . The method of  claim 5 , wherein the GLP-1 molecule is a GLP-1 analog.  
     
     
         14 . The method of  claim 4  wherein the GLP-1 molecule comprises Valine, Glycine, or Threonine at position 8.  
     
     
         15 . The method of  claim 1 , wherein the composition is administered as a controlled release preparation.  
     
     
         16 . A pharmaceutical composition comprising a GLP-1 molecule or an analog or derivative thereof and a thiazolidinedione compound.  
     
     
         17 . The pharmaceutical composition of  claim 16  wherein the thiazolidinedione is troglitazone.  
     
     
         18 . The pharmaceutical composition of  claim 16  wherein the thiazolidinedione is ciglitazone.  
     
     
         19 . The pharmaceutical composition of  claim 16  wherein the GLP-1 molecule is GLP-1(7-36) or GLP-1(7-37).  
     
     
         20 . The pharmaceutical composition of  claim 16  wherein the GLP-1 molecule is an analog or derivative of His 7 -Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Lys-Gly-Arg 36 -X, where X is NH 2  or Gly.  
     
     
         21 . The pharmaceutical composition of  claim 20  wherein the GLP-1 molecule is a GLP-1 derivative.  
     
     
         22 . The pharmaceutical composition of  claim 20  wherein the GLP-1 molecule is a GLP-1 analog.  
     
     
         23 . The pharmaceutical composition of  claim 19  wherein the GLP-1 molecule comprises Valine, Glycine, or Threonine at position 8.  
     
     
         24 . A composition of matter comprising: (i) a container suitable for holding a liquid preparation to be infused in a patient; (ii) a liquid preparation comprising a GLP-1 molecule or an analog or derivative thereof, and a pharmaceutically acceptable carrier such that the GLP-1 molecule or analog or derivative is present in a concentration of at least about 2 mg/ml; and (iii) instructions on infusing a patient with said preparation, said patient suffering from non-insulin dependent diabetes mellitus (NIDDM), such that said patient receives an infusion of the preparation.  
     
     
         25 . A composition of  claim 24 , wherein the concentration of GLP-1 molecule or analog or derivative is at least about 5 mg/ml.  
     
     
         26 . A composition of  claim 24 , wherein the concentration of GLP-1 molecule or analog or derivative is at least about 10 mg/ml.  
     
     
         27 . A composition of  claim 24 , wherein the concentration of GLP-1 molecule or analog or derivative is about 2 to about 100 mg/ml.  
     
     
         28 . A composition of  claim 24 , wherein the GLP-1 molecule is GLP-1(7-36) or GLP-1(7-37).  
     
     
         29 . A composition of  claim 24 , wherein the GLP-1 molecule is an analog or derivative of His 7 -Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Lys-Gly-Arg 36 -X, where X is NH 2  or Gly.  
     
     
         30 . A composition of  claim 28 , wherein the GLP-1 molecule comprises Valine, Glycine or Threonine at position 8.  
     
     
         31 . A composition of  claim 24 , further comprising a second preparation comprising a thiazolidinedione compound.  
     
     
         32 . A composition of  claim 31 , wherein the thiazolidinedione is troglitazone.  
     
     
         33 . A composition of  claim 31 , wherein the thiazolidinedione is ciglitazone.  
     
     
         34 . A composition of  claim 31 , wherein the GLP-1 molecule is GLP-1(7-36) or GLP-1(7-37).  
     
     
         35 . A composition of  claim 31 , wherein the GLP-1 molecule is an analog or derivative of His 7 -Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Lys-Gly-Arg 36 -X, where X is NH 2  or Gly.  
     
     
         36 . A composition of  claim 34 , wherein the GLP-1 molecule comprises Valine, Glycine or Threonine at position 8.  
     
     
         37 . A composition of  claim 31 , wherein the concentration of GLP-1 molecule or analog or derivative is at least about 2 mg/ml.  
     
     
         38 . A composition of  claim 31 , wherein the concentration of GLP-1 molecule or analog or derivative is at about 2 to about 100 mg/ml.

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