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Title:
MULTIPLE AGENT DIABETES THERAPY
Document Type and Number:
WIPO Patent Application WO/2001/000223
Kind Code:
A2
Abstract:
A pharmaceutical composition includes at least two of agents I)- iii), wherein agent (i) is selected from the group consisting of an insulin, an insulin analog, a physiologically active fragment of said insulin and a physiologically active fragment of said insulin analog, agent (ii) is selected from the group consisting of an insulin-related peptide, an insulin-related peptide analog, a physiologically active insulin-related peptide fragment and a physiologically active insulin-related peptide analog fragment, and agent (iii) is an insulin sensitizer.

Inventors:
VAN ANTWERP WILLIAM P
PFUETZNER ANDREAS H R
Application Number:
PCT/US2000/017268
Publication Date:
January 04, 2001
Filing Date:
June 23, 2000
Export Citation:
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Assignee:
MINIMED INC (US)
International Classes:
A61K31/427; A61K38/28; A61K9/10; A61K38/30; A61K45/00; A61K47/02; A61K47/04; A61K47/10; A61K47/34; A61M1/36; A61P3/10; (IPC1-7): A61K38/00
Domestic Patent References:
WO1992020366A11992-11-26
WO1996002270A11996-02-01
WO1998057636A11998-12-23
WO1999043705A11999-09-02
Foreign References:
US5783556A1998-07-21
US4988675A1991-01-29
US5641744A1997-06-24
US4652548A1987-03-24
Attorney, Agent or Firm:
Kovelman, Paul H. (CA, US)
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Claims:
WHAT IS CLAIMED IS:
1. A pharmaceutical composition comprising at least two of agents i) iii), wherein agent i) is selected from the group consisting of an insulin, an insulin analog, a physiologically active fragment of said insulin and a physiologically active fragment of said insulin analog, agent ii) is selected from the group consisting of an insulinrelated peptide, an insulinrelated peptide analog, a physiologically active insulin related peptide fragment and a physiologically active insulinrelated peptide analog fragment, and agent iii) is an insulin sensitizer.
2. The composition of claim 1 wherein said agent i) is an insulin.
3. The composition of claim 2 wherein said insulin is selected from the group consisting of human insulin, porcine insulin and bovine insulin.
4. The composition of claim 1 wherein said agent i) is an insulin analog.
5. The composition of claim 4 wherein said insulin analog is selected from the group consisting of LysB28 insulin, ProB29 insulin and As insulin.
6. The composition of claim 1 wherein said agent ii) is an insulinrelated peptide.
7. The composition of claim 6 wherein said peptide is selected from the group consisting of Cpeptide, GLP1, amylin, IGF1 and IGF1 bound to binding protein 3.
8. The composition of claim 1 wherein said agent iii) is an insulin sensitizer of the glitazone family.
9. The composition of claim 1 which is stabilized for administration by a medication infusion pump.
10. The composition of claim 1 comprising agent i) and agent ii).
11. The composition of claim 1 comprising about 1.5 to about 40 mg/ml of agent i) and about 1.5 to about 40 mg/ml of agent ii).
12. The composition of claim 10 further comprising a pharmaceutically acceptable nonionic surfactant.
13. The composition of claim 12 wherein said nonionic surfactant is a block copolymer of propylene oxide and ethylene oxide.
14. The composition of claim 13 comprising about 1.5 to about 40 mg/ml of agent i), about 1.5 to about 40 mg/ml of agent ii) and an amount of said nonionic surfactant affording a concentration less than the critical micellar concentration of said composition.
15. The composition of claim 9 further comprising agent iii).
16. The composition of claim 1 comprising agent i) and agent iii).
17. The composition of claim 16 comprising about 0.5 to about 40 mg/ml of agent i) and about 0.05 to about 12 mg/ml of agent iii).
18. The composition of claim 1 comprising agent ii) and agent iii).
19. The composition of claim 18 comprising comprising about 0.05 to about 12.5 mg/ml of agent ii) and about 0.05 to about 12.5 mg/ml of agent iii).
20. The composition of claim 1 comprising two or more compounds of agents i), ii) or iii).
21. A pharmaceutical composition comprising i) at least one agent selected from the group consisting of an insulin, an insulin analog, a physiologically active insulin fragment and a physiologically active insulin analog fragment and ii) at least one agent selected from the group consisting of an insulinrelated peptide, an insulinrelated peptide analog, a physiologically active insulinrelated peptide fragment and a physiologically active insulated related peptide analog fragment, wherein said agent ii) comprises a hydrophobic portion that is coated with a pharmaceutically acceptable nonionic surfactant.
22. The pharmaceutical composition of claim 21 wherein said nonionic surfactant is a block copolymer of propylene oxide and ethylene oxide.
23. The pharmaceutical composition of claim 21 further comprising a pharmaceutically acceptable carrier.
24. The pharmaceutical composition of claim 21 further comprising iii) an insulin sensitizer.
25. The composition of claim 21 which is stabilized for administration by a medication infusion pump.
26. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 1.
27. The method of claim 26 wherein said composition is administered to said patient by a medication infusion pump.
28. The method of claim 27 wherein said medication infusion pump is reusable.
29. The method of claim 27 wherein said medication infusion pump is nonreusable.
30. The method of claim 27 wherein said medication infusion pump is implantable.
31. The method of claim 27 wherein said medication infusion pump is externally mountable.
32. The method of claim 26 wherein said composition is administered continually.
33. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 10.
34. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 12.
35. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 15.
36. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 16.
37. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 18.
38. The method of claim 37 wherein said diabetes is type 2 diabetes.
39. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 20.
40. A method of treating diabetes comprising the step of administering to a patient in need of such treatment the pharmaceutical composition of claim 21.
41. A method of treating diabetes comprising the step of administering to a patient in need of such treatment at least two pharmaceutical compositions a)c), wherein composition a) comprises i) at least one agent selected from the group consisting of an insulin, an insulin analog, a physiologically active fragment of said insulin and a physiologically active fragment of said insulin analog, and ii) a pharmaceutically acceptable carrier, composition b) comprises i) at least one agent selected from the group consisting of an insulinrelated peptide, an insulinrelated peptide analog, a physiologically active insulinrelated peptide fragment and a physiologically active insulinrelated peptide analog fragment, and ii) a pharmaceutically acceptable carrier, and composition c) comprises i) an insulin sensitizer, and ii) a pharmaceutically acceptable carrier.
42. The method of claim 41 wherein each of said compositions is administered to said patient using a separate delivery device.
43. The method of claim 42 wherein each said delivery device is a medication infusion pump.
44. The method of claim 41 wherein each of said compositions is administered at a different rate.
45. The method of claim 41 wherein each of said compositions is administered continually.
46. The method of claim 41 wherein compositions a) and b) are administered to said patient.
47. The method of claim 46 wherein said composition b) further comprises at least one pharmaceutically acceptable nonionic surfactant.
48. The method of claim 41 wherein compositions a) and c) are administered to said patient.
49. The method of claim 41 wherein compositions b) and c) are administered to said patient.
50. The method of claim 41 wherein compositions a), b) and c) are administered to said patient.
51. A method of making a pharmaceutical composition useful in treating diabetes, said method comprising the step of combining at least two of agents i)iii), wherein agent i) is selected from the group consisting of an insulin, an insulin analog, a physiologically active fragment of said insulin and a physiologically active fragment of said insulin analog, agent ii) is selected from the group consisting of an insulinrelated peptide, an insulinrelated peptide analog, a physiologically active insulin related peptide fragment and a physiologically active insulinrelated peptide analog fragment, and agent iii) is an insulin sensitizer.
52. The method of claim 51 wherein said agents are combined with a pharmaceutically a. cceptable carrier.
53. The method of claim 51 wherein agents i) and ii) are combined.
54. The method of claim 52 wherein agents i) and ii) are combined with a pharmaceutically acceptable nonionic surfactant.
55. The method of claim 51 wherein agents i) and iii) are combined.
56. The method of claim 51 wherein agents ii) and iii) are combined.
57. The method of claim 51 wherein agents i), ii) and iii) are combined.
58. A method of treating diabetes and at least one side effect thereof which comprises the step of administering to a patient in need of such treatment a pharmaceutical composition comprising a) at least one agent selected from the group consisting of an insulin, an insulin analog, a physiologically active insulin fragment and a physiologically active insulin analog fragment, b) at least one agent selected from the group consisting of an insulinrelated peptide, an insulinrelated peptide analog, a physiologically active insulinrelated peptide fragment and a physiologically active insulin related peptide analog fragment, wherein said agent is effective in treating said side effect, and c) a pharmaceutically acceptable nonionic surfactant.
59. A pharmaceutical composition comprising at least two of agents i) iii), wherein agent i) is selected from the group consisting of an insulin mimetic material, agent ii) is selected from the group consisting of an insulinrelated peptide, an insulinrelated peptide analog, a physiologically active insulin related peptide fragment and a physiologically active insulinrelated peptide analog fragment, and agent iii) is an insulin sensitizer.
60. The composition of claim 59 wherein said agent i) is a small molecule insulin.
61. The composition of claim 60 wherein the small molecule insulin mimetic material is L783,281.
62. The composition of claim 59 wherein said agent ii) is an insulin related peptide.
63. The composition of claim 62 wherein said peptide is selected from the group consisting of Cpeptide, GLP1, amylin, IGF1 and IGF1 bound to binding protein 3.
64. The composition of claim 59 wherein said agent iii) is an insulin sensitizer of the glitazone family.
65. The composition of claim 59 which is stabilized for administration by a medication infusion pump.
66. The composition of claim 59 comprising agent i) and agent ii).
67. The composition of claim 66 further comprising a pharmaceutically acceptable nonionic surfactant.
68. The composition of claim 67 wherein said nonionic surfactant is a block copolymer of propylene oxide and ethylene oxide.
69. The composition of claim 65 further comprising agent iii).
70. The composition of claim 59 comprising agent i) and agent iii).
71. The composition of claim 59 comprising two or more compounds of agents i), ii) or iii).
Description:
INTERNATIONAL SEARCH REPORT Tinter mal Application No PCT/US00/17268 C. (Continuation) DOCUMENTS CONSIDERED TO BE RELEVANT Category ° Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. X US 4 988 675 A (FROESCH E. R. ET AL.) 1-3,6,7, 29 January 1991 (1991-01-29) 10-14, 20-23, 26, 33, 34, 39-41, 51-53, 58-63 the whole document X WO 92 20366 A (AMYLIN PHAMACEUTICALS) 1-3,6,7, 26 November 1992 (1992-11-26) 10-14, 20-23, 26,33, 34, 39-41, 51-53, 58-63 the whole document X US 5 641 744 A (COOPER G. J. S.) 1-3,6,7, 24 June 1997 (1997-06-24) 10-14, 20-23, 26,33, 34, 39-41, 51-53, 58-63 the whole document X WO 96 02270 A (GROPEP PTY) 1-3,6,7, 1 February 1996 (1996-02-01) 10-14, 20-23, 26, 33, 34, 39-41, 51-53, 58-63 the whole document X US 4 652 548 A (CHANCE R. E ET AL.) 1-3,6,7, 24 March 1987 (1987-03-24) 10-14, 20-23, 26,33, 34, 39-41, 51-53, 58-63 the whole document

INTERNATIONAL SEARCH REPORT Inten nal Application No PCT/US 00/17268 C. (Continuation) DOCUMENTS CONSIDERED TO BE RELEVANT Category o Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. X WO 98 57636 A (SMITHKLINE BEECHAM) 1-3,8, 23 December 1998 (1998-12-23) 15-17, 20-24, 26,35, 36, 39-41, 51,52, 55,58-63 the whole document P, X WO 99 43705 A (NOVO NORDISK) 1-3,6,7, 2 September 1999 (1999-09-02) 10-14, 20-23, 26,33, 34, 39-41, 51-53, 58-63 claims 112, 113 INTERNATIONAL SEARCH REPORT Inten nal Application No . ormation on patent family members PCT/US 00/17268 Patent document Publication Patent family Publication cited in search report date member (s) date US 5783556 A 21-07-1998 AU 3824397 A 06-03-1998 CA 2261799 A 19-02-1998 EP 0918536 A 02-06-1999 WO 9806423 A 19-02-1998 ZA 9706598 A 17-02-1999 US 4988675 A 29-01-1991 AT 86497 T 15-03-1993 AU 2899989 A 10-08-1989 CA 1336815 A 29-08-1995 DE 68905205 D 15-04-1993 DE 68905205 T 22-07-1993 DK 52189 A 06-08-1989 EP 0331630 A 06-09-1989 IE 63163 B 22-03-1995 IL 104777 A 07-10-1994 JP 1233227 A 19-09-1989 JP 2831017 B 02-12-1998 KR 131087 B 17-04-1998 NZ 227857 A 28-04-1992 NZ 241617 A 24-06-1997 PH 26085 A 06-02-1992 ZA 8900855 A 25-10-1989 WO 9220366 A 26-11-1992 AT 170401 T 15-09-1998 AT 157010 T 15-09-1997 AT 197764 T 15-12-2000 AU 648895 B 05-05-1994 AU 1687392 A 21-10-1992 AU 669110 B 30-05-1996 AU 2011592 A 30-12-1992 AU 2169392 A 30-12-1992 AU 6196496 A 10-10-1996 CA 2082928 A 16-09-1992 CA 2109604 A 26-11-1992 CA 2109794 A 26-11-1992 DE 69221725 D 25-09-1997 DE 69221725 T 18-12-1997 DE 69226835 D 08-10-1998 DE 69226835 T 14-01-1999 DE 69231583 D 04-01-2001 DK 533898 T 31-05-1999 DK 586589 T 22-09-1997 EP 0533898 A 31-03-1993 EP 0586589 A 16-03-1994 EP 0586592 A 16-03-1994 ES 2122995 T 01-01-1999 ES 2108122 T 16-12-1997 JP 6510753 T 01-12-1994 JP 6510754 T 01-12-1994 MX 9201110 A 01-07-1993 SG 49239 A 18-05-1998 SG 44838 A 19-12-1997 WO 9216222 A 01-10-1992 WO 9220367 A 26-11-1992 US 5656590 A 12-08-1997 US 5508260 A 16-04-1996 US 5814600 A 29-09-1998 US 5527771 A 18-06-1996 INTFRNATIONAL SEARCH !------------------- ! Interi nal Application No ., ormation on patent family members PCT/US 00/17268 PCT/US 00/17268 Patent document Publication cited in search report date member (s) date WO 9220366 A US 5321008 A 14-06-1994 US 5641744 A 24-06-1997 AT 155688 T 15-08-1997 AU 634954 B 11-03-1993 AU 2157588 A 20-07-1989 DE 3855970 D 04-09-1997 DE 3855970 T 29-01-1998 DK 473888 A 05-04-1989 EP 0309100 A 29-03-1989 EP 0787741 A 06-08-1997 ES 2106721 T 16-11-1997 FI 883936 A 27-02-1989 GR 3024705 T 31-12-1997 HK 1000934 A 08-05-1998 JP 1096137 A 14-04-1989 JP 2828250 B 25-11-1998 NO 883828 A 27-02-1989 US 5367052 A 22-11-1994 US 5124314 A 23-06-1992 US 5175145 A 29-12-1992 WO 9602270 A 01-02-1996 AU 2917495 A 16-02-1996 US 4652548 A 24-03-1987 AU 551734 B 08-05-1986 AU 8759782 A 03-03-1983 BE 894187 A 24-02-1983 CA 1176159 A 16-10-1984 CH 650680 A 15-08-1985 DE 3232035 A 10-03-1983 FR 2511868 A 04-03-1983 GB 2104381 A, B 09-03-1983 IL 66612 A 29-11-1985 IT 1153183 B 14-01-1987 JP 58046026 A 17-03-1983 LU 84357 A 28-02-1983 MW 3982 A 13-06-1984 NL 8203313 A 16-03-1983 NZ 201685 A 13-09-1985 PH 18640 A 23-08-1985 SE 8204872 A 25-08-1982 ZA 8206160 A 25-04-1984 ZW 17682 A 24-11-1982 WO 9857636 A 23-12-1998 AU 8216398 A 04-01-1999 BG 104059 A 31-10-2000 BR 9810444 A 05-09-2000 CN 1260715 T 19-07-2000 EP 0999837 A 17-05-2000 NO 996265 A 17-12-1999 WO 9943705 A 02-09-1999 AU 2610599 A 15-09-1999 EP 1056774 A 06-12-2000




 
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