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Claims for Patent: 8,329,648

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Claims for Patent: 8,329,648

Title:Methods for treating diabetes and reducing body weight
Abstract: Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA.sub.1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.
Inventor(s): Fineman; Mark (San Diego, CA), MacConell; Leigh (San Diego, CA), Taylor; Kristin (San Diego, CA)
Assignee: Amylin Pharmaceuticals, LLC (San Diego, CA)
Application Number:13/084,757
Patent Claims: 1. A method for treating diabetes in a human in need thereof comprising administering to the human an effective amount of a pharmaceutical composition comprising a biocompatible poly(lactide-co-glycolide) copolymer and exendin-4 or an exendin analog to achieve a mean steady state plasma concentration of the exendin-4 or the exendin-4 analog at least 170 pg/ml for at least one month in the human to treat diabetes.

2. The method of claim 1, wherein the pharmaceutical composition comprises exendin-4.

3. The method of claim 2, wherein the pharmaceutical composition further comprises a sugar.

4. The method of claim 1, wherein the pharmaceutical composition comprises the exendin analog.

5. The method of claim 4, wherein the exendin analog comprises the amino acid sequence of any one of SEQ ID NOs: 2 and 9-142.

6. The method of claim 1, wherein the poly(lactide-co-glycolide) copolymer is purified 50:50 (lactide:glycolide) poly(D,L-lactide-co-glycolide).

7. The method of claim 1, wherein the pharmaceutical composition is administered to the human once weekly.

8. The method of claim 1, wherein the exendin-4 or the exendin analog is present in the pharmaceutical composition in an amount of 1.0 mg to 5.0 mg.

9. The method of claim 1, wherein the pharmaceutical composition comprises 5% (w/w) exendin-4, 2% (w/w) sucrose, and 93% (w/w) poly(lactide-co-glycolide)copolymer.

10. The method of claim 1, wherein the mean steady state plasma concentration of exendin-4 or the exendin analog is 170 pg/ml to 600 pg/ml.

11. The method of claim 1, wherein the mean steady state plasma concentration of exendin-4 or the exendin analog is 170 pg/ml to 350 pg/ml.

12. The method of claim 1, wherein the mean steady state plasma concentration of exendin-4 or the exendin analog is 170 pg/ml to 290 pg/ml.

13. The method of claim 1, wherein the diabetes is type 2 diabetes.

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

15. A method for reducing one or more of HbA1C, fasting plasma glucose, and body weight in a human in need thereof comprising administering to the human an effective amount of a pharmaceutical composition comprising a biocompatible poly(lactide-co-glycolide) copolymer and exendin-4 or an exendin analog in an amount to achieve a mean steady state concentration of exendin-4 or the exendin analog of at least 170 pg/ml for at least one month to reduce one or more of HbA1C, fasting plasma glucose, and body weight.

16. The method of claim 15, wherein the pharmaceutical composition comprises exendin-4.

17. The method of claim 15, wherein the method is for reducing HbA1C.

18. The method of claim 15, wherein the method is for reducing fasting plasma glucose.

19. The method of claim 15, wherein the method is for reducing body weight.

20. A method for treating type 2 diabetes in a human in need thereof comprising administering once weekly to the human an effective amount of a pharmaceutical composition comprising 5% (w/w) exendin-4, 2% (w/w) sucrose, and 93% (w/w) poly(lactide-co-glycolide)copolymer to achieve a mean steady state plasma concentration of exendin-4 at 170 pg/ml to 350 pg/ml for at least one month in the human to treat Type 2 diabetes.
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