GLP-1 pharmaceutical compositions

1. A pharmaceutical composition comprising an analog of glucagon-like peptide-1 according to the formula:

[Aib 8,35 ]hGLP-1(7-36)NH 2 ;

together with zinc and a pharmaceutically acceptable carrier or diluent, wherein said diluent comprises a pharmaceutically acceptable aqueous solution and said pharmaceutical composition is a clear solution when said composition is administered, said analog of glucagon-like peptide-1 is released within said subject for at least approximately two weeks, with the proviso that said composition does not consist of a clear aqueous ZnCl 2 solution having pH 4 in which said [Aib 8,35 ]hGLP-1(7-36)NH 2 is present at a concentration of 4 mg/ml and said ZnCl 2 is present at a concentration of 0.5 mg/ml.

2. The pharmaceutical composition according to claim 1 , wherein said zinc is present in a concentration from 0.0005 mg/mL to 50 mg/mL.

3. The pharmaceutical composition according to claim 2 , wherein said zinc is present in a concentration from 0.01 mg/mL to 0.50 mg/mL.

4. The pharmaceutical composition according to claim 1 , wherein said diluent comprises sterile water.

5. The pharmaceutical composition according to claim 1 , wherein said pharmaceutical composition comprises an aqueous mixture, suspension or solution, and wherein said analog of glucagon-like peptide-1 is present at a concentration of approximately 0.5%-30% (w/w).

6. The pharmaceutical composition according to claim 5 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous mixture, suspension or solution is approximately 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, or 30% (w/w).

7. The pharmaceutical composition according to claim 6 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 14%, 15%, 16%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 29%, or 30% (w/w).

8. The pharmaceutical composition according to claim 7 , wherein the concentration of said analog: of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 3%, 4%, 5%, 6%, 9%, 10%, 11%, 22%, 23%, 24%, 25%, or 26% (w/w).

9. The pharmaceutical composition according to claim 8 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 3%, 4%, 5%, 6%, 10%, 22%, 23%, 24%, 25%, or 26% (w/w).

10. The pharmaceutical composition according to claim 9 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 5%, 10%, 23% or 25% (w/w).

11. The pharmaceutical composition according to claim 5 , wherein the molar ratio of said analog of glucagon-like peptide-1 to zinc in said pharmaceutical composition ranges from approximately 6:1 to approximately 1:1.

12. The pharmaceutical composition according to claim 11 , wherein said ratio ranges from approximately 5.5:1 to approximately 1:1.

13. The pharmaceutical composition according to claim 12 , wherein said ratio ranges from approximately 5.4:1 to approximately 1.5:1.

14. The pharmaceutical composition according to claim 13 , wherein said ratio is approximately 5.4:1, 4.0:1, or 1.5:1.

15. The pharmaceutical composition according to claim 14 , wherein said ratio is approximately 1.5:1.

16. The pharmaceutical composition according to claim 5 , wherein said zinc is provided as zinc chloride or zinc acetate.

17. The pharmaceutical composition according to claim 16 , wherein said zinc acetate is provided as ZnAc 2 .2H 2 O.

18. The pharmaceutical composition according to claim 1 , wherein when said composition is administered to said subject in need thereof, said analog of glucagon-like peptide-1 is released within said subject for at least approximately three weeks.

19. The pharmaceutical composition according to claim 1 , wherein when said composition is administered to said subject in need thereof, the analog of glucagon-like peptide-1 is released within said subject for at least approximately four weeks.

20. The pharmaceutical composition according to claim 11 , wherein when said composition is administered to said subject in need thereof, said analog of glucagon-like peptide-1 is released within said subject for at least approximately three weeks.

21. The pharmaceutical composition according to claim 11 , wherein when said composition is administered to said subject in need thereof, the analog of glucagon-like peptide-1 is released within said subject for at least approximately four weeks.

22. The pharmaceutical composition according to any one of claims 18 - 19 , wherein said subject is a mammal.

23. The pharmaceutical composition according to any one of claims 20 - 21 , wherein said subject is a mammal.

24. The composition according to claim 15 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 1% (weight/volume).

25. The composition according to claim 15 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 2% (weight/volume).

26. The composition according to claim 15 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 10% (weight/volume).

27. The composition according to claim 15 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 25% (weight/volume).

28. The composition according to claim 14 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 5% (weight/volume) and said ratio is approximately 5.4:1.

29. The composition according to claim 14 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 5% (weight/volume) and said ratio is approximately 4.0:1.

30. The composition according to claim 14 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 said composition is about 10% (weight/volume) and said ratio is approximately 5.4:1.

31. The composition according to claim 14 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 23% (weight/volume) and said ratio is approximately 4.0:1.

32. The composition according to claim 15 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said composition is about 23% (weight/volume).

33. The pharmaceutical composition according to claim 22 , wherein said subject is a human.

34. The pharmaceutical composition according to claim 23 , wherein said subject is a human.

35. The composition according to claim 15 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2 in said pharmaceutical composition is about 10% (weight/volume) and the molar ratio of [Aib 8,35 ]hGLP-1(7-36)NH 2 to zinc is about 1.5:1.

36. A method of treating a subject afflicted with Type I diabetes, Type II diabetes or gestational diabetes comprising administering to said subject the pharmaceutical composition according to claim 1 .

37. The method according to claim 36 , wherein said subject is a human being.

38. The method according to claim 37 , wherein said disease is Type I diabetes or Type II diabetes.

39. A method of stimulating beta-cell proliferation or reducing beta-cell deterioration comprising administering to a subject in need thereof the pharmaceutical composition according to claim 1 .

40. The method according to claim 39 , wherein said subject is a human being.

41. A method of treating a subject afflicted with Type I diabetes, Type II diabetes or gestational diabetes comprising administering to said subject the pharmaceutical composition according to claim 5 .

42. The method according to claim 41 , wherein said subject is a human being.

43. The method according to claim 42 , wherein said disease is Type I diabetes or Type II diabetes.

44. A method of stimulating beta-cell proliferation or reducing beta-cell deterioration comprising administering to a subject in need thereof the pharmaceutical composition according to claim 5 .

45. The method according to claim 32 , wherein said subject is a human being.