Claims for Patent: 9,884,094

Summary for Patent: 9,884,094

Title:	Method of treating diabetes mellitus
Abstract:	A combination comprising at least a first insulin-like compound and a second insulin-like compound for treating a condition or a disease in a subject in need thereof where administration of insulin would be of benefit to said subject is described. The combination is administered in an amount to achieve a beneficial glycaemic control in said subject as determined by the levels of HbA.sub.1c in said subject after administration of said combination at the largest meal of the day for said subject; wherein said beneficial glycaemic control by said combination is superior to any glycaemic control achieved by an equivalent dose of IGlar in said subject as determined by the levels of HbA.sub.1c in said subject after administration of IGlar for said subject and/or wherein said beneficial glycaemic control by said combination comprises decreasing the levels of HbA.sub.1c in said subject to about 7 or less after administration of said combination at the largest meal of the day; wherein said first insulin-like compound is longer acting than the second insulin-like compound; wherein said combination is administered at the largest meal of the day for said subject; wherein said first insulin-like compound is at least a long acting insulin, preferably an ultra long acting insulin; wherein said first insulin-like compound is a derivative of a naturally occurring insulin or is an insulin analog; and wherein said first insulin-like compound has a side chain attached to the a-amino group of the N-terminal amino acid residue of the B chain or to the .epsilon.-amino group of a Lys residue present in the B chain of the parent insulin, the side chain being of the general formula (I): --W--X--Y--Z.
Inventor(s):	Johansen; Thue (Koebenhavn, DK), Mersebach; Henriette (Hellerup, DK), Axelsen; Mads (Virum, DK), Lange; Martin (Bagsvaerd, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	14/398,018
Patent Claims:	1. A method for treating diabetes mellitus comprising: administering to a subject in need thereof, during or around the time of the largest meal of the day for said subject, a pharmaceutically acceptable combination comprising LysB29(N.epsilon.-hexadecandioyl-.gamma.-Glu) des(B30) human insulin and Asp.sup.B28 human insulin; wherein the ratio of the combination administered is selected from about 90/10%, about 85/15%, about 80/20%, about 70/30%, about 60/40%, about 50/50%, about 40/60%, about 30/70%, or about 10/90%; wherein said combination is administered in an amount to achieve a beneficial glycaemic control in said subject as determined by the levels of HbA.sub.1c in said subject; wherein said beneficial glycaemic control by said combination is superior to any glycaemic control achieved by an equivalent dose of insulin glargine (IGlar) in said subject as determined by the levels of HbA.sub.1c in said subject after administration of IGlar to said subject; wherein said beneficial glycaemic control by said combination comprises decreasing the levels of HbA.sub.1c in said subject to about 7 or less; and wherein said decrease in levels of HbA1.sub.c is achieved in about 26 weeks or less. 2. A method according to claim 1 wherein the combination is a fixed-dose or single formulation. 3. A method according to claim 1 wherein the combination comprises separate formulations concomitantly or sequentially administered. 4. A method according to claim 2 wherein the ratio of LysB29(N.epsilon.-hexadecandioyl-.gamma.-Glu) des(B30) human insulin to Asp.sup.B28 human insulin is about 70/30%. 5. A method according to claim 3 wherein the ratio of LysB29(N.epsilon.-hexadecandioyl-.gamma.-Glu) des(B30) human insulin to Asp.sup.B28 human insulin is about 70/30%.

Details for Patent 9,884,094

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	04/20/2000		2032-05-01
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	04/25/2007		2032-05-01
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	12/16/2015		2032-05-01
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	11/15/2019		2032-05-01
Mylan Pharmaceuticals Inc.	SEMGLEE	insulin glargine	Injection	210605	06/11/2020		2032-05-01