US2022347269A1PendingUtilityA1

Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin

Assignee: SANOFI AVENTIS DEUTSCHLANDPriority: May 13, 2011Filed: Mar 15, 2022Published: Nov 3, 2022
Est. expiryMay 13, 2031(~4.8 yrs left)· nominal 20-yr term from priority
A61K 38/28A61P 3/10A61K 38/26A61P 3/04A61K 2300/00A61K 31/155A61K 9/0019A61P 3/00A61P 43/00A61K 2121/00A61K 9/0053A61K 9/0002A61K 2123/00
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Claims

Abstract

The present invention refers to a pharmaceutical combination for use in glycemic control in diabetes type 2 patients.

Claims

exact text as granted — not AI-modified
1 . A method for inducing weight loss or preventing weight gain in a type 2 diabetes mellitus patient comprising administering to the patient in need thereof a pharmaceutical combination comprising:
 (a) desPro 36 Exendin-4(1-39)-Lys 6 -NH 2  or a pharmaceutically acceptable salt thereof,   (b) a basal insulin or a pharmaceutically acceptable salt thereof, and   (c) optionally metformin or a pharmaceutically acceptable salt thereof.   
     
     
         2 . The method of  claim 1 , wherein the desPro 36 Exendin-4(1-39)-Lys 6 -NH 2  or the pharmaceutically acceptable salt thereof is prepared for administration in a daily dose between about 10 μg to about 20 μg. 
     
     
         3 . The method of  claim 1 , wherein the basal insulin is insulin glargine. 
     
     
         4 . The method of  claim 1 , wherein the metformin or the pharmaceutically acceptable salt thereof is prepared for oral administration. 
     
     
         5 . The method of  claim 1 , wherein the patient is obese. 
     
     
         6 . The method of  claim 5 , wherein the patient has a body mass index of at least 30 kg/m 2 . 
     
     
         7 . The method of  claim 1 , wherein the patient is an adult patient. 
     
     
         8 . The method of  claim 1 , wherein the patient has not received prior antidiabetic treatment. 
     
     
         9 . The method of  claim 1 , wherein the patient's type 2 diabetes mellitus has been diagnosed at least 1 or 2 years before onset of therapy. 
     
     
         10 . The method of  claim 1 , wherein the patient has a HbAlc value of about 7% to about 10%. 
     
     
         11 . The method of  claim 1 , wherein the patient has a fasting plasma glucose concentration of at least 8 mmol/L. 
     
     
         12 . The method of  claim 1 , wherein the patient has a glucose excursion of at least 2 mmol/L.

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