BALAGLITAZONE COMPOSITIONS AND METHODS

• US 20130109620A1
• Filed: 12/17/2010
• Published: 05/02/2013
• Est. Priority Date: 12/18/2009
• Status: Abandoned Application

• Current Assignee: Dr. Reddy's Laboratories Ltd., Rheoscience A/S
• Original Assignee: Reddy's Laboratories Limited, Rheoscience A/S
• Inventors: Henriksen, Kim, Kumar, Rajinder, Riis, Bente
• Application Number:
  US13/516,917
• Publication Number:
  US 20130109620A1
• Time in Patent Office: Days
• US Class Current: 514/6.5
• CPC Class Codes: A61K 31/517 ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Methods for reducing bone loss in a subject suffering from a condition benefiting from a decrease in insulin resistance, by balaglitazone administration to the subject.

Claims

1-40. -40. (canceled)

41. A method for improving or maintaining bone density or bone mineral content, or both, in a subject suffering from insulin resistance comprising administering balaglitazone in an amount effective to improve or maintain bone density while decreasing insulin resistance.

45. The method of claim 41, 42, 43, or 44, wherein the subject is a human.

46. The method of claim 41, 42, 43, or 44, wherein a rate of bone formation by osteoblasts is maintained during said administration.

47. The method of claim 41, 42, 43, or 44, wherein blood glucose control is improved in the subject.

48. The method of claim 41, 42, 43, or 44, wherein said subject is selected from population of patients suffering from an increased risk of bone fracture related to the patients'"'"' population'"'"'s age, sex, and weight demographics.

49. The method of claim 41, 42, 43, or 44, wherein the subject is an adult and balaglitazone is administered to the subject at a dose from about 5 mg to about 15 mg per day.

50. The method of claim 49, wherein the dose is from about 9 to about 12 mg per day.

51. The method of claim 49, wherein the dose is from about 9.5 to about 10.5 mg per day.

52. The method of claim 49, wherein the dose is about 5 mg per day.

53. The method of claim 41, 42, 43, or 44, further comprising administering an effective amount of insulin to said subject.

54. The method of claim 50, wherein the subject receives stable insulin therapy.

55. The method of claim 41, 42, 43, or 44, wherein the subject has a condition selected from the group consisting one or more of type 2 diabetes, dyslipidemia, hyperglycemia, hyperinsulinemia, insulin resistance, obesity, cardiovascular complications, atherosclerosis, hypertension, impaired glucose tolerance, impaired fasting glucose level, increased plasma levels of free fatty acids, increased plasma levels of triglycerides, and increased plasma levels of very low density lipoproteins.

56. The method of claim 41, 42, 43, or 44, wherein the subject has a condition including one or more of osteoporosis, achondroplasia, bone and joint infections, bone cancer, bone fractures, craniosynostosis, curvature of the spine, enchondroma, fibrodysplasiaossificans progressive, fibrous dysplasia, giant cell tumor of bone, infectious arthritis, Klippel-feil syndrome, Legg Calve Perthes disease, myeloma, Osgood-Schlater disease, OsteitisCondensansllii, osteochondritisdissecans-OCD, osteochondroma—

bone tumor, osteogenesis, osteomalacia, osteomyelitis, osteonecrosis, osteopenia, osteopetrosis, osteophytes, Paget'"'"'s disease, Proteus syndrome, renal osteodystrophy, rickets, scoliosis, charcot joint, diabetic hand syndrome, osteoarthritis, diffuse idiopathic skeletal hyperostosis, Dupuytren contracture, frozen shoulder, and unicameral bone cyst.

57. The method of claim 41, 42, 43, or 44, wherein a serum bone alkaline phosphatase level of the subject after balaglitazone administration is substantially maintained at a pre-administration level.

58. The method of claim 41, 42, 43, or 44, wherein a serum osteocalcin level of the subject after balaglitazone administration is substantially maintained at a pre-administration level.

59. The method of claim 41, 42, 43, or 44, wherein a bone mineral density of the subject after balaglitazone administration is substantially maintained at a pre-administration level.

60. The method of claim 41, 42, 43, or 44, further comprising administering an additional therapeutic agent for restricting bone loss.

61. The method of claim 60, wherein the additional therapeutic agent for restricting bone loss is selected from the group consisting of one or more of vitamin A, vitamin D2, vitamin D, calcium, an analgesic, a non-steroidal anti-inflammatory drug, a cyclooxygenase-2 inhibitor, acetaminophen, a chemotherapy drug, an antibiotic, an antifungal, a corticosteroid, and cinacalcet hydrochloride.

63. The method of claim 41, 42, 43, or 44, comprising decreasing insulin resistance in said subject, wherein the subject has a condition selected from the group consisting one or more of type 2 diabetes, dyslipidemia, hyperglycemia, hyperinsulinemia, insulin resistance, obesity, cardiovascular complications, atherosclerosis, hypertension, impaired glucose tolerance, impaired fasting glucose level, increased plasma levels of free fatty acids, increased plasma levels of triglycerides, and increased plasma levels of very low density lipoproteins.

42. A method of reducing the risk or incidence of bone fracture in a subject suffering from insulin resistance comprising administering balaglitazone in an amount effective to reduce the risk or incidence of bone fracture while decreasing insulin resistance.

43. A method of decreasing the rate of bone degradation in a subject suffering from insulin resistance comprising administering balaglitazone in an amount effective to decrease the rate of bone degradation while decreasing insulin resistance.

44. A method of reducing bone loss in a subject suffering from insulin resistance comprising administering balaglitazone in an amount effective to decrease reduce the bone loss while decreasing insulin resistance.

62. A method for providing blood glucose control in a subject suffering from a condition benefiting from a decrease in insulin resistance, wherein the subject is selected based upon an increased risk of bone fracture for the subject'"'"'s age, sex, and/or weight demographics, the method comprising administering balaglitazone to the subject.