Treatment of genotyped diabetic patients with DPP-IV inhibitors such as linagliptin

• US 10,092,571 B2
• Filed: 08/12/2016
• Issued: 10/09/2018
• Est. Priority Date: 11/27/2009
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Dugi, Klaus, Graefe-Mody, Eva Ulrike, Mark, Michael, Woerle, Hans-Juergen, Zimdahl-Gelling, Heike
• Primary Examiner(s): Ha, Julie
• Assistant Examiner(s): Hellman, Kristina M
• Application Number:
  US15/235,575
• Publication Number:
  US 20160354380A1
• Time in Patent Office: 788 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 31/4985 Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/513 having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 38/26 Glucagons
• 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
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

The present invention relates to methods for preventing or treating of metabolic disorders and related conditions, such as in certain patient groups.

Claims

1. A method for treating type 2 diabetes mellitus in a patient in need thereof, wherein the patient has type 2 diabetes and has at least one T allele in the single nucleotide polymorphism (SNP) rs7903146 in the gene coding for TCF7L2,

said method comprising testing whether the type 2 diabetes patient has at least one T allele in the single nucleotide polymorphism (SNP) rs7903146 in the gene coding for TCF7L2, and

administering a DPP-4 inhibitor selected from linagliptin, sitagliptin, vildagliptin, alogliptin, saxagliptin, teneligliptin and dutogliptin, and, optionally, a second antidiabetic agent selected from biguanides, thiazolidindiones, sulfonylureas, glinides, inhibitors of alpha-glucosidase, GLP-1 or GLP-1 analogues, and insulin or insulin analogues, and, optionally, a third antidiabetic agent selected from biguanides, thiazolidindiones, sulfonylureas, glinides, inhibitors of alpha-glucosidase, GLP-1 or GLP-1 analogues, and insulin or insulin analogues, to the patient, optionally in combination, including in alternation.

2. The method according to claim 1 wherein the patient has insufficient glycemic control despite diet and exercise, or despite monotherapy with the second or the third antidiabetic agent.

3. The method according to claim 1 wherein the patient has insufficient glycemic control despite diet and exercise, or despite dual therapy with the second and the third antidiabetic agent.

4. The method according to claim 1 wherein the patient has insufficient glycemic control despite diet and exercise, or despite monotherapy with either the DPP-4 inhibitor or the second or third antidiabetic agent, or despite dual therapy with the second and the third antidiabetic agent.

5. The method according to claim 1 wherein the patient has insufficient glycemic control despite diet and exercise, or despite monotherapy with either the DPP-4 inhibitor, the second or the third antidiabetic agent, or despite combination therapy with two agents selected from the group of the DPP-4 inhibitor, the second and the third antidiabetic agent.

6. The method according to claim 1 wherein the patient is diagnosed for, has been diagnosed with, or carries two T alleles of SNP rs7903146 of TCF7L2.

7. The method according to claim 1 wherein the patient is diagnosed for, has been diagnosed with, or carries one T allele of SNP rs7903146 of TCF7L2.

8. The method according to claim 1 wherein the DPP-4 inhibitor is linagliptin.

9. The method according to claim 1 wherein the DPP-4 inhibitor is linagliptin, and the second antidiabetic agent is metformin or pioglitazone.