Claims for Patent: 10,137,172

Summary for Patent: 10,137,172

Title:	Administration regime
Abstract:	The invention relates to a novel administration regime useful in the treatment of diseases or conditions where administration of insulin will be of benefit, as well as to kits for use in the same. In particular, the invention relates to a long-acting or ultra-long acting insulin for use in treating a disease or condition where administration of insulin will be of benefit, wherein the administration of said insulin comprises or consists of the following steps: (a) optionally providing a blood sample to be tested from an individual in need of treatment; (b) taking a single fasting blood (or plasma) glucose measurement from said individual in need of treatment; (c) using the single fasting blood (or plasma) glucose measurement to determine the insulin dose to be administered; and (d) administering the long-acting or ultra-long insulin to the individual at the dose determined in step (c).
Inventor(s):	Johansen; Thue (Koebenhavn OE, DK), Francisco; Ann Marie Ocampo (Copenhagen V, DK), Christensen; Torsten (Princeton, NJ), Kongsoe; Jens Harald (Hoersholm, DK), Ahlgreen; Trine (Frederiksberg C, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	14/888,118
Patent Claims:	1. An insulin titration method comprising: (a) obtaining a fasting blood or plasma sample, or non-invasive glucose measurement from an individual in need of treatment of type 2 diabetes; (b) performing a single fasting blood or plasma glucose measurement on the sample obtained in (a); (c) using the single fasting blood or plasma glucose measurement obtained in (b) to determine a LysB29(N.epsilon.-hexadecandioyl-.gamma.-Glu) des(B30) human insulin (insulin degludec) dose to be administered; and (d) administering said insulin to the individual at the dose determined in step (c); wherein subsequent doses of insulin are titrated by repeating step (a) and (b), the measurement being: .ltoreq.3.9 mmol/L (.ltoreq.70 mg/dL): the dose administered in step (d) is reduced by 4 U compared to the dose previously administered; or 4 to 5 mmol/L (71 to 90 mg/dL): the dose administered in step (d) is unaltered compared to the dose previously administered; or .gtoreq.5.1 mmol/L (.gtoreq.91 mg/dL): the dose administered in step (d) is increased by 4 U compared to the dose previously administered; wherein step (d) is performed for an administration period of at least 3 days between two consecutive titrations; and wherein comparable improvements in HbA.sub.1c levels are seen relative to titration methods that are based on an average of at least three consecutive fasting blood glucose measurements per week. 2. The method according to claim 1, further comprising the following-step: (e) repeating steps (a) to (d). 3. The method according to claim 1, wherein steps (a) to (c) are performed on the same day, wherein, in step (d), said insulin is administered for an administration period of at least 3 days, and starting on the same day as steps (a) to (c), and wherein said steps (a) to (d) are repeated continuously as long as needed by the said individual in need of treatment. 4. The method according to a claim 1, wherein said insulin is administered, either concurrently or consecutively, with one or more additional drugs used in the treatment of diabetes. 5. The method according to claim 4 wherein said insulin is administered concurrently or consecutively with liraglutide.

Details for Patent 10,137,172

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	September 25, 2015		2034-04-30
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	November 21, 2018		2034-04-30