Amylin Pharmaceuticals, Inc.

Garth J Cooper

Andrew A Young

Brendan Leighton

Timothy J Rink

Candace X Moore

Antony C Willis

Novel methods for use in identifying or assaying compounds which can simulate the ability of amylin to cause hyperlactemia and hyperglycemia in in vivo biological models, or for use in evaluating the potency of compounds known or suspected to simulate these actions of amylin, which involve introducing test samples into in vivo test systems and determining the presence or amount of a rise in lactate, or determining the presence or amount of a rise in lactate and a rise in glucose, following test sample administration.

Amylin activity assays

A biologically active peptide associated with diabetes and designated herein 'amylin' and processes for preparing it and assaying for it and for Type 2 diabetes are disclosed. The invention includes peptides having the amino acid sequence KCNTATCATQRLANFLVHSSNNFGAILSSTNVGSNTY, substantially homologous sequences of amino acids, proamylin, as well as biologically active subfragments and conservative mutations. The peptide may be prepared from diabetic pancreata by solubilization of amyloid and isolation of the peptide by gel filtration and reverse phase chromotography. Amylin may also be synthesized, or it may be produced by recombinant DNA techniques using the disclosed nucleic acid sequences.

Amylin peptides

The administration of antagonists and blockers of amylin or CGRP or both for the treatment of obesity and essential hypertension and associated lipid disorders and atherosclerosis.

Treatment of obesity and essential hypertension and related disorders

Non-insulin dependent, or type 2, diabetes mellitus in a patient is treated by administering to the patient a hypoglycemic agent that enhances plasma concentrations of amylin and a therapeutically effective amount of an amylin antagonist. Hypoglycemic agents which enhance plasma concentrations of amylin can be sulfonylureas such as glibenclamide and tolbutamide. Amylin antagonists can be amylin 8-37 and CGRP 8-37. Administration of the amylin antagonist in conjunction with the hypoglycemic agent also enhances the blood glucose lowering effects of the hypoglycemic agent.

Hypoglycemics

Compositions having amylin or an amylin agonist and a glucagon compound, particularly peptide compounds, for the control of glucose production in mammals are provided. The compositions are useful in the treatment of hypoglycemia, including acute hypoglycemic conditions such as those brought on by insulin overdose and the overuse of oral hypoglycemic agents.

Hyperglycemic compositions

The present invention relates to pharmaceutical compositions for use in treating diabetes Mellitus or hypoglycemia containing Amylin as the effective additive.

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Solana Beach, CA, United States of America

Garth J Cooper