Method for reducing cardiovascular morbidity and mortality in prediabetic patients and patients with type 2 diabetes

• US 7,405,196 B2
• Filed: 01/14/2004
• Issued: 07/29/2008
• Est. Priority Date: 01/14/2003
• Status: Active Grant

• Current Assignee: Aventisub LLC (Sanofi )
• Original Assignee: Aventis Pharmaceuticals Incorporated (Sanofi-Aventis U.S., LLC)
• Inventors: Gerstein, Hertzel, Rosskamp, Ralf
• Primary Examiner(s): BRADLEY, CHRISTINA
• Application Number:
  US10/757,201
• Publication Number:
  US 20040229774A1
• Time in Patent Office: 1,658 Days
• Field of Search: None
• US Class Current: 514/5.9
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

This invention relates to a method of reducing cardiovascular morbidity and mortality in a prediabetic or Type 2 Diabetes patient population. The method comprises administering an effective dosage of a long acting insulin, preferably insulin glargine, to a prediabetic or Type 2 Diabetes patient.

Claims

1. A method of treating impaired glucose tolerance (IGT) in a patient in need thereof comprising administering an effective dosage of a long acting insulin.

2. The method of claim 1 wherein the long acting insulin is insulin glargine.

3. The method of claim 2 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

4. The method of claim 3 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

5. The method of claim 4 wherein the effective dosage is in the range of about 2 to about 40 IU per day.

6. The method of claim 1 wherein the patient has a history of one or more cardiovascular events or risk factors selected from the group consisting of:

myocardial infarction, stroke, angina with documented ischemic changes, coronary, carotid or peripheral arterial revascularization, and left ventricular hypertrophy.

7. The method of claim 2 wherein the patient has one or more cardiovascular risk factors selected from the group consisting of:

previous myocardial infarction, stroke, angina with documented ischemic changes, previous coronary, carotid or peripheral arterial revascularization, and left ventricular hypertrophy.

8. A method of treating impaired fasting glucose (IFG) in a patient in need thereof comprising administering an effective dosage of a long acting insulin.

9. The method of claim 8 wherein the long acting insulin is insulin glargine.

10. The method of claim 9 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

11. The method of claim 10 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

12. The method of claim 11 wherein the effective dosage is in the range of about 2 to about 40 IU per day.

13. The method of claim 8 wherein the patient has a history of one or more cardiovascular events or risk factors selected from the group consisting of:

myocardial infarction, stroke, angina with documented ischemic changes, coronary, carotid or peripheral arterial revascularization, and left ventricular hypertrophy.

14. The method of claim 9 wherein the patient has one or more cardiovascular risk factors selected from the group consisting of:

previous myocardial infarction, stroke, angina with documented ischemic changes, previous coronary, carotid or peripheral arterial revascularization, and left ventricular hypertrophy.

15. A method of treating early Type 2 diabetes in a patient in need thereof comprising administering an effective dosage of a long acting insulin.

16. The method of claim 15 wherein the long acting insulin is insulin glargine.

17. The method of claim 16 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

18. The method of claim 17 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

19. The method of claim 18 wherein the effective dosage is in the range of about 2 to about 40 IU per day.

20. The method of claim 15 wherein the patient has a history of one or more cardiovascular events or risk factors selected from the group consisting of:

myocardial infarction, stroke, angina with documented ischemic changes, coronary, carotid or peripheral arterial revascularization, and left ventricular hypertrophy.

21. The method of claim 16 wherein the patient has one or more cardiovascular risk factors selected from the group consisting of:

previous myocardial infarction, stroke, angina with documented ischemic changes, previous coronary, carotid or peripheral arterial revascularization, and left ventricular hypertrophy.

22. A method of treating diabetic dyslipidemia in a Type 2 diabetes patient comprising administering an effective dosage of a long acting insulin.

23. The method of claim 22 wherein the long acting insulin is insulin glargine.

24. The method of claim 23 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

25. The method of claim 24 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

26. The method of claim 25 wherein the effective dosage is in the range of about 2 to about 40 IU per day.

27. The method of claim 23 wherein the Type 2 diabetes patient was previously treated with only diet and/or exercise.

28. The method of claim 23 wherein the Type 2 diabetes patient is drug naï

ve.

29. A method of treating atherosclerosis in a patient diagnosed with a disease or condition selected from the group consisting of IFG, IGT, and early Type 2 diabetes, comprising administering an effective dosage of a long acting insulin.

30. The method of claim 29 wherein the long acting insulin is insulin glargine.

31. The method of claim 30 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

32. The method of claim 31 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

33. The method of claim 32 wherein the effective dosage is in the range of about 2 to about 40 IU per day.

34. A method of improving endothelial function in a patient diagnosed with a disease or condition selected from the group consisting of IFG, IGT, and early Type 2 diabetes, comprising administering an effective dosage of a long acting insulin.

35. The method of claim 34 wherein the long acting insulin is insulin glargine.

36. The method of claim 35 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

37. The method of claim 36 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

38. The method of claim 37 wherein the effective dosage is in the range of about 2 to about 40 IU per day.

39. A method of improving left ventricular diastolic and systolic function in a patient diagnosed with a disease or condition selected from the group consisting of IFG, IGT, and early Type 2 diabetes, comprising administering an effective dosage of a long acting insulin.

40. The method of claim 39 wherein the long acting insulin is insulin glargine.

41. The method of claim 40 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

42. The method of claim 41 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

43. The method of claim 42 wherein the effective dosage is in the range of about 2 to about 40 IU per day.

44. A method of reducing blood glucose levels in a patient diagnosed with a disease or condition selected from the group consisting of IFG, IGT, and early Type 2 diabetes, comprising administering an effective dosage of a long acting insulin.

45. The method of claim 44 wherein the long acting insulin is insulin glargine.

46. The method of claim 45 wherein the effective dosage is in the range of about 2 to about 150 IU per day.

47. The method of claim 46 wherein the effective dosage is in the range of about 2 to about 80 IU per day.

48. The method of claim 47 wherein the effective dosage is in the range of about 2 to about 40 IU per day.