Method for treating type II diabetes mellitus

• US 6,147,108 A
• Filed: 10/04/1999
• Issued: 11/14/2000
• Est. Priority Date: 02/05/1997
• Status: Expired due to Term

• Current Assignee: Cheplapharm Arzneimittel GmbH
• Original Assignee: Hoffmann-La Roche Incorporated (Roche Holding AG)
• Inventors: Hauptman, Jonathan Brian
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US09/411,554
• Time in Patent Office: 407 Days
• Field of Search: 514/449, 514/866, 514/909
• US Class Current: 514/449
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/365 Lactones
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

A method for treating or preventing type II diabetes mellitus comprising administering an effective amount of a gastrointestinal lipase inhibitor, such as, tetrahydrolipstatin.

Claims

1. A method of treating type II diabetes mellitus by reducing hemoglobin A1c levels, which comprises orally administering to a human subject afflicted with type II diabetes mellitus an amount of a pharmaceutical preparation in unit dosage form, which consists essentially of tetrahydrolipstatin formulated as an oral composition, the amount of tetrahydrolipstatin being effective to reduce hemoglobin A1c levels and in the range of from about 60 to 720 mg of tetrahydrolipstatin per day.

2. The method of claim 1, wherein the pharmaceutical preparation is administered from two to three times per day.

3. The method of claim 2, wherein the pharmaceutical preparation is administered three times per day.

4. The method of claim 1, wherein the pharmaceutical preparation is administered to provide tetrahydrolipstatin at a dose in the range of about 180 to 360 mg per day.

5. The method of claim 4, wherein the pharmaceutical preparation is administered to provide tetrahydrolipstatin at a dose of about 360 mg per day.

6. The method of claim 5, wherein the pharmaceutical preparation is administered from two to three times per day.

7. The method of claim 6, wherein the pharmaceutical preparation is administered three times per day.

8. The method of claim 1, wherein the subject is obese or overweight.

9. The method of claim 1, wherein the subject is not obese or overweight.

10. The method of claim 2, wherein the pharmaceutical preparation is administered within about two hours of ingestion of a meal containing fat.

11. The method of claim 10, wherein the pharmaceutical preparation is administered within about one hour of ingestion of a meal containing fat.

12. The method of claim 6, wherein the pharmaceutical preparation is administered within about two hours of ingestion of a meal containing fat.