IP Library Granted Patent US 8,623,817
Granted Patent B2
US 8,623,817 · App. 13/351,855 · Granted Jan 7, 2014

Method of treating diabetes type 2 by administering ultrarapid acting insulin

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Quick Facts
Patent No.
US 8,623,817
App. No.
13/351,855
Granted
Jan 7, 2014
Kind
B2
Abstract

Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.

Claims (23)

1. A method of treating diabetes type 2, comprising:

selecting a patient with diabetes type 2 currently being treated with a suppressor of hepatic glucose output and an insulin secretagogue;

discontinuing treatment with the insulin secretagogue; and

routinely administering an ultrarapid acting insulin preparation with at least one established meal.

2. The method of claim 1 wherein treatment with the suppressor of hepatic glucose output is also discontinued.

3. The method of claim 2 wherein the patient is further selected for having an insulin resistance at the lower portion of the insulin resistance spectrum.

4. The method of claim 1 wherein the patient is further selected for needing to reduce or avoid weight gain.

5. The method of claim 1 wherein the administering step does not comprise an injection.

6. The method of claim 5 wherein patient is further a candidate for treatment with insulin and is further selected on the basis of being needle-phobic or desiring to avoid frequent injections.

7. The method of claim 1 wherein the suppressor of hepatic glucose output is metformin.

8. The method of claim 1 wherein the insulin secretagogue is a sulfonylurea.

9. The method of claim 1 wherein the patient is further selected for having well or moderately controlled fasting blood glucose.

10. The method of claim 1 wherein the ultrarapid acting insulin preparation is administered by inhalation.

11. The method of claim 10 wherein the ultrarapid acting insulin preparation is a dry powder.

12. The method of claim 11 wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin.

13. The method of claim 11 wherein ultrarapid acting insulin preparation comprises insulin-FDKP.

14. The method of claim 1 wherein the patient is further selected for having an HbA1c level ≧8.

15. The method of claim 1 wherein the patient is further selected for having an elevated mean amplitude of glucose excursions.

16. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered with each meal containing more than 15 g of carbohydrate.

17. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered at a dosage sufficient to maximally reduce hepatic glucose output within 60 minutes of administration.

18. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered at a dosage within the range of 1 to 32 subcutaneous equivalent units.

19. The method of claim 1 wherein the ultrarapid acting insulin preparation comprises an insulin analog.

20. The method of claim 19 wherein the insulin analog is insulin aspart, insulin glulisine, or insulin lispro.

Assignments (8)
PATENT SECURITY AGREEMENT Recorded Aug 12, 2025
From: MANNKIND CORPORATION
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 072444/0525 →
RELEASE OF SECURITY INTEREST Recorded Apr 5, 2024
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: MANNKIND CORPORATION; MANNKIND LLC
Reel/Frame 067024/0082 →
RELEASE OF SECURITY INTEREST Recorded Aug 13, 2019
From: DEERFIELD PRIVATE DESIGN FUND II, L.P.; DEERFIELD PRIVATE DESIGN INTERNATIONAL II, L.P.; HORIZON SANTE FLML SARL
To: MANNKIND CORPORATION
Reel/Frame 050044/0138 →
SECURITY INTEREST Recorded Aug 13, 2019
From: MANNKIND CORPORATION; MANNKIND LLC
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 050044/0181 →
RELEASE OF SECURITY INTEREST Recorded Nov 10, 2016
From: AVENTISUB LLC
To: MANNKIND CORPORATION
Reel/Frame 040588/0008 →
PATENT SECURITY AGREEMENT Recorded Sep 26, 2014
From: MANNKIND CORPORATION
To: AVENTISUB LLC
Reel/Frame 033831/0110 →
SECURITY AGREEMENT Recorded Jul 3, 2013
From: MANNKIND CORPORATION
To: DEERFIELD PRIVATE DESIGN FUND II, L.P.; DEERFIELD PRIVATE DESIGN INTERNATIONAL II, L.P.; HORIZON SANTE FLML SARL
Reel/Frame 030740/0123 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2012
From: RICHARDSON, PETER; BAUGHMAN, ROBERT A.; POTOCKA, ELIZABETH; BOSS, ANDERS HASAGER; PETRUCCI, RICHARD
To: MANNKIND CORPORATION
Reel/Frame 027543/0963 →