NZ763815B2 - Methods of using and compositions containing dulaglutide - Google Patents

Methods of using and compositions containing dulaglutide Download PDF

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Publication number
NZ763815B2
NZ763815B2 NZ763815A NZ76381518A NZ763815B2 NZ 763815 B2 NZ763815 B2 NZ 763815B2 NZ 763815 A NZ763815 A NZ 763815A NZ 76381518 A NZ76381518 A NZ 76381518A NZ 763815 B2 NZ763815 B2 NZ 763815B2
Authority
NZ
New Zealand
Prior art keywords
dulaglutide
dose
once weekly
methods
compositions containing
Prior art date
Application number
NZ763815A
Other versions
NZ763815A (en
Inventor
David Andrew Cox
Zvonko Milicevic
Lai San Tham
Andrew Gordon Werner
David Bradley Woodward
Original Assignee
Eli Lilly And Company
Filing date
Publication date
Application filed by Eli Lilly And Company filed Critical Eli Lilly And Company
Priority claimed from PCT/US2018/060716 external-priority patent/WO2019103875A2/en
Publication of NZ763815A publication Critical patent/NZ763815A/en
Publication of NZ763815B2 publication Critical patent/NZ763815B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Abstract

The present invention relates to methods of using new doses of dulaglutide and compositions containing such higher doses of dulaglutide given in a dosage regime with increasing dosages from 0.75 mg weekly up to 4.5 mg weekly resulting in less side effects.

Claims (4)

WE CLAIM:
1. Use of dulaglutide in the manufacture of a medicament for improving glycemic control in a subject in need thereof with type 2 diabetes, wherein: a) said medicament is to be administered to said subject in an initial dose of 5 0.75 mg of dulaglutide once weekly; b) said dose is to be increased to 1.5 mg of dulaglutide once weekly c) said dose is to be increased to 3.0 mg of dulaglutide once weekly after at least 4 weeks on the 1.5 mg dose; and d) said dose is to be increased to 4.5 mg of dulaglutide once weekly after at 10 least 4 weeks on the 3.0 mg dose.
2. The use of claim 1, wherein the dose increases of each of steps b) through d) are performed when there is a need to reduce the subject’s HbA1c level.
3. The use of claim 2, wherein administration of 4.5 mg of dulaglutide once weekly results in a greater body weight reduction than administration of 1.5 mg of 15 dulaglutide once weekly.
4. Use of any one of claims 1 to 3 substantially as herein described with reference to any example thereof.
NZ763815A 2018-11-13 Methods of using and compositions containing dulaglutide NZ763815B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762589244P 2017-11-21 2017-11-21
PCT/US2018/060716 WO2019103875A2 (en) 2017-11-21 2018-11-13 Methods of using and compositions containing dulaglutide

Publications (2)

Publication Number Publication Date
NZ763815A NZ763815A (en) 2023-11-24
NZ763815B2 true NZ763815B2 (en) 2024-02-27

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