Novo Nordisk A/s

Dorte Bjerre Steensgaard

Morten Schlein

Svend Havelund

Mathias Norrman

Christian Poulsen

Susanne Hostrup

Holger Martin Strauss

Rosa Rebecca Erritzoee Hansen

Jesper Soendergaard Pedersen

Peter Madsen

Palle Jakobsen

Frantisek Hubalek

Svend Ludvigsen

Anders Klarskov Petersen

Niels Christian Kaarsholm

Helle Birk Olsen

Soren Ostergaard

Jens Kaalby Thomsen

Ingrid Petterson

Helle Naver

Anne Plum

Kasper Huus

Anne Sofie Kajær Markussen

Rosa Rebecca Erritzøe Hansen

Jesper Søndergaard Pedersen

Anne Sofie Kjær Marcussen

Ingrid Vivika Petterson

Anne Sofie Kjær Markussen

The present invention is in the field of pharmaceutical compositions for the treatment of medical conditions relating to diabetes. More specifically the invention provides pharmaceutical compositions comprising a long-acting acylated derivative of a human insulin analogue, and to the medical use of such compositions for basal insulin administration therapy.

Insulin containing pharmaceutical compositions

The present invention is in the field of pharmaceutical compositions for the treatment of medical conditions relating to diabetes. More specifically the invention provides pharmaceutical compositions comprising a long-acting acylated derivative of a human insulin analog, and to the medical use of such compositions for basal insulin administration therapy.

A stable pharmaceutical formulation containing an insulin derivative can conveniently be prepared by adding glycerol, phenol, m-cresol and zinc ions to it.

Insulin formulations

The invention concerns a soluble pharmaceutical formulation comprising an insulin derivative wherein the formulation further comprises more than 4 zinc atoms per 6 molecules of the insulin derivative, and a citric acid monohydrate and/or a histidine compound used in an amount sufficient to increase the tendency of the insulin derivative to self-associate into dodecamers. The invention further comprises a process for preparing the soluble pharmaceutical formulation.

Pharmaceutical formulations comprising an insulin derivative

Pharmaceutical composition for parenteral administration comprising a basal insulin peptide and an insulinotropic GLP-1 peptide comprising at least 6 zinc atoms per 6 insulin molecules.

Pharmaceutical compositions comprising GLP-1 peptides or extendin-4 and a basal insulin peptide

The present invention relates to novel ligands for the HisZnsites of the R-state insulin hexamer having the formula A-B-C-D-X (III), wherein: A is a chemical group which reversibly binds to a HisZnsites of an insulin hexamer; B is a linker; C is a fragment consisting of 0 to 5 neutral amino acids; D is a fragment comprising 1 to 20 positively charged groups independently selected from amino or guanidino groups; and X is &#x2014;OH, &#x2014;NHor a diamino group. The present invention also relates to R-state insulin hexamers comprising such ligands, and aqueous insulin preparations comprising such R-state insulin hexamers.

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Maaloev, Denmark

Dorte Bjerre Steensgaard