US 12,239,739 B2
Oral dosing of GLP-1 compounds
Flemming S. Nielsen, Frederikssund (DK); and Per Sauerberg, Farum (DK)
Assigned to Novo Nordisk A/S, Bagsvaerd (DK)
Filed by Novo Nordisk A/S, Bagsvaerd (DK)
Filed on Mar. 22, 2019, as Appl. No. 16/361,971.
Application 16/361,971 is a continuation of application No. 15/651,043, filed on Jul. 17, 2017, granted, now 10,278,923.
Application 15/651,043 is a continuation of application No. 14/785,493, abandoned, previously published as PCT/EP2014/058974, filed on May 2, 2014.
Claims priority of application No. 13166205 (EP), filed on May 2, 2013.
Prior Publication US 2019/0216739 A1, Jul. 18, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/26 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61P 3/04 (2006.01); A61P 3/10 (2006.01); A61K 31/166 (2006.01)
CPC A61K 9/2013 (2013.01) [A61K 9/0053 (2013.01); A61K 38/26 (2013.01); A61P 3/04 (2018.01); A61P 3/10 (2018.01); A61K 9/2054 (2013.01); A61K 31/166 (2013.01)] 27 Claims
 
1. A method for treating type 2 diabetes and/or reducing body weight in a subject in need of such treatment, the method comprising:
orally administering to the subject a therapeutically effective amount of a solid oral dosage form composition comprising a glucagon-like peptide-1 (GLP-1) peptide and an enhancer,
wherein:
(a) the GLP-1 peptide is N-epsilon26-[2-(2-{2-[2-(2-{2- [(S)-4-Carboxy-4-(17-carboxyheptadecanoyl-amino) butyrylamino] ethoxy} ethoxy) acetylamino] ethoxy} ethoxy) acetyl] [Aib8,Arg34] GLP-1-(7-37) (semaglutide); and
(b) the enhancer is sodium N-(8-(2-hydroxybenzoyl) amino) caprylate (SNAC);
wherein semaglutide is the only GLP-1 peptide administered;
wherein the composition is administered daily for a period of 70 days; and
wherein the variability in plasma exposure of said GLP-1 peptide is reduced when compared to a single dose of the GLP-1 peptide.