Claims for Patent: 9,884,092

Summary for Patent: 9,884,092

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 (Wilmington, DE) AstraZeneca Pharmaceuticals LP (Wilmington, DE)
Application Number:	15/168,350
Patent Claims:	1. A method for treating diabetes in a human in need thereof, the method comprising administering to the human an effective amount of a sustained release pharmaceutical composition comprising exendin-4 or an exendin analog to achieve a mean steady state plasma concentration of the exendin-4 or the exendin analog of at least 200 pg/ml for at least one month in the human to treat diabetes. 2. The method of claim 1, wherein the sustained release pharmaceutical composition is administered in a continuous mode. 3. The method of claim 2, wherein the continuous mode results from administering the sustained release composition once weekly by subcutaneous injection. 4. The method of claim 3, wherein 2 mg of the exendin-4 or exendin analog agonist are administered once weekly. 5. The method of claim 1, wherein the sustained release pharmaceutical composition comprises exendin-4. 6. The method of claim 1, wherein the sustained release pharmaceutical composition comprises the exendin analog. 7. The method of claim 6, wherein the exendin analog comprises the amino acid sequence of any one of SEQ ID NOs: 2 and 9-142. 8. The method of claim 1, wherein the sustained release pharmaceutical composition further comprises a sugar. 9. The method of claim 1, wherein the sustained release pharmaceutical composition further comprises a poly(lactide-co-glycolide) copolymer. 10. The method of claim 9, wherein the poly(lactide-co-glycolide) copolymer is purified 50:50 (lactide:glycolide) poly(D,L-lactide-co-glycolide). 11. The method of claim 1, wherein the sustained release pharmaceutical composition comprises 5% (w/w) exendin-4, 2% (w/w) sucrose, and 93% (w/w) poly(lactide-co-glycolide)copolymer. 12. The method of claim 1, wherein the sustained minimum plasma concentration of the exendin-4 or the exendin analog agonist is between 200 pg/ml to 350 pg/ml. 13. The method of claim 1, wherein the exendin-4 or exendin analog agonist is co-administered with metformin, a sulphonylurea, a thiazolidinedione or any combination thereof. 14. The method of claim 1, wherein the diabetes is type 2 diabetes. 15. A method for reducing HbA1C, fasting plasma glucose, or body weight in a human in need thereof, the method comprising administering to the human in a continuous mode an effective amount of a sustained release pharmaceutical composition comprising 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 200 pg/ml for at least one month to reduce HbA1C, fasting plasma glucose, or body weight. 16. The method of claim 15, wherein the continuous mode is achieved by once weekly administration of a subcutaneous injection. 17. The method of claim 15, wherein the sustained release pharmaceutical composition comprises 5% (w/w) exendin-4, 2% (w/w) sucrose, and 93% (w/w) poly(lactide-co-glycolide)copolymer. 18. The method of claim 15, wherein the method is for reducing HbA1C. 19. The method of claim 15, wherein the method is for reducing fasting plasma glucose. 20. The method of claim 15, wherein the method is for reducing body weight. 21. The method of claim 15, wherein the sustained minimum plasma concentration of the exendin-4 or the exendin analog agonist is between 200 pg/ml to 350 pg/ml. 22. The method of claim 15, wherein the exendin-4 or exendin analog agonist is co-administered with metformin, a sulphonylurea, a thiazolidinedione or any combination thereof.