IP Library › Granted Patent US 9,821,032
Granted Patent B2
US 9,821,032 · App. 13/467,707 · Granted Nov 21, 2017

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

Inventors: Elisabeth Niemoeller (Frankfurt am Main, DE); Louise Silvestre (Paris, FR); Gabor Boka (Paris, FR); Patrick Miossec (Paris, FR)
Assignee: SANOFI-AVENTIS DEUTSCHLAND GMBH
A61K38/26A61K31/155A61K38/28
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Quick Facts
Patent No.
US 9,821,032
App. No.
13/467,707
Granted
Nov 21, 2017
Kind
B2
Abstract

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

Claims (20)

1. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising administering to the patient in need thereof a therapeutically effective amount of a pharmaceutical combination comprising:

(a) lixisenatide or a pharmaceutically acceptable salt thereof, and

(b) insulin glargine or a pharmaceutically acceptable salt thereof,

wherein the patient's type 2 diabetes mellitus is inadequately controlled after treatment with basal insulin at a dose of about 15 units to about 80 units per day for at least about 3 months.

2. The method of claim 1 , wherein the patient is an adult.

3. The method of claim 1 , wherein the patient has a glycosylated hemoglobin A 1c (HbA 1c ) value of about 7% to about 10% after treatment with basal insulin.

4. The method of claim 1 , wherein the basal insulin is insulin glargine.

5. The method of claim 1 , wherein the pharmaceutical combination comprises a daily dose of about 15 units to about 80 units of insulin glargine.

6. The method of claim 1 , wherein the pharmaceutical combination comprises a daily dose of about 10 μg to about 20 μg of lixisenatide.

7. A method for improving glycemic control in a patient with type 2 diabetes mellitus, the method comprising administering to the patient in need thereof a therapeutically effective amount of a pharmaceutical combination comprising:

(a) lixisenatide or a pharmaceutically acceptable salt thereof, and

(b) insulin glargine or a pharmaceutically acceptable salt thereof,

wherein the patient's type 2 diabetes mellitus is inadequately controlled after treatment with basal insulin at a dose of about 15 units to about 80 units per day and metformin at a dose of at least about 1.0 g per day for at least about 3 months.

8. The method of claim 7 , wherein the basal insulin is insulin glargine.

9. The method of claim 7 , wherein the pharmaceutical combination comprises a daily dose of about 15 units to about 80 units of insulin glargine.

10. The method of claim 7 , wherein the pharmaceutical combination comprises a daily dose of about 10 μg to about 20 μg of lixisenatide.

11. The method of claim 7 , wherein the patient is an adult.

12. The method of claim 7 , wherein the patient has an HbA 1c value of about 7% to about 10% after treatment with basal insulin and metformin.

13. The method of claim 7 , further comprising administering to the patient a therapeutically effective amount of metformin.

14. The method of claim 1 or 7 , wherein the basal insulin is a long-acting basal insulin.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 12, 2012
From: NIEMOELLER, ELISABETH; SILVESTRE, LOUISE; MIOSSEC, PATRICK; BOKA, GABOR
To: SANOFI-AVENTIS DEUTSCHLAND GMBH
Reel/Frame 028940/0376 →
Priority Claims (1)
EP 11166111 · May 13, 2011 · regional
Continuity (1)
Related Publication 20130005649A1 · Jan 3, 2013