EP0309100A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Use of amylin or CGRP for the treatment of diabetes mellitus
Assignee: Amylin Pharmaceuticals LLC
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Filing: 1988-08-26
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Granted: —
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Expires: 2008-08-26
Abstract
Abstract Amylin or amylin-NH₂ or CGRP or a functional peptide fragment of amylin or amylin-NH₂ or CGRP, or a conservative variant of the amylin or amylin-NH₂ or CGRP or fragment, is provided as well as a soluble amylin or amylin-amide or active subfragment thereof or a lyophilized product for use in the treatment of diabetes mellitus or hypoglycaemia. Methods for preparation thereof are provided.
Inventors
- 👤 Garth James Smith Cooper
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 18:32
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/225; A61K33/00; A61K33/24; A61K33/30; A61K38/28; A61P; A61P3/00; A61P3/08; A61P3/10; A61P5/00; A61P5/48; C; C07; C07K; C07K14/00; C07K14/435; C07K14/575
Claims Analysis
Total Claims: 59
Claim 1
Independent Claim
40 words
Amylin or amylin-NH₂ or CGRP or a functional peptide fragment of amylin or amylin-NH₂ or CGRP, or a conservative variant of the amylin or amylin- NH₂ or CGRP or fragment, for use in the treatment of diabetes mellitus or hypoglycaemia.
Claim 2
Dependent Claim
40 words
Amylin or amylin-NH₂ or CGRP or a functional peptide fragment of amylin or amylin-NH₂ or CGRP, or a conservative variant of the amylin or amylin- NH₂ or CGRP or fragment, for use in the treatment of diabetes mellitus or hypoglycaemia.
Claim 3
Dependent Claim
46 words
A composition comprising a) insulin and b) amylin or amylin-NH₂ or CGRP, or a functional peptide fragment of amylin or amylin-NH₂ or CGRP or a conservative variant of the amylin or amylin-NH₂ or CGRP or fragment, for use in the treatment of diabetes mellitus or hypoglycaemia.
Claim 4
Dependent Claim
46 words
A composition comprising a) insulin and b) amylin or amylin-NH₂ or CGRP, or a functional peptide fragment of amylin or amylin-NH₂ or CGRP or a conservative variant of the amylin or amylin-NH₂ or CGRP or fragment, for use in the treatment of diabetes mellitus or hypoglycaemia.
Claim 5
Dependent Claim
28 words
A composition as claimed in claim 2, wherein the molar ratio of insulin to amylin or amylin-NH₂ or CGRP (or fragment or variant) is from 100:1 to 0.1:1.
Claim 6
Dependent Claim
21 words
A product according to any one of claims 1 to 3, in the form of a solution suitable for parenteral administration.
Claim 7
Independent Claim
52 words
A method of preparing a product for the treatment of diabetes mellitus or hypoglycaemia, which method comprises bringing an active ingredient selected from amylin, amylin-NH₂, CGRP, functional peptide fragments thereof and conservative variants of the amylin or amylin-NH₂ or CGRP or fragment, into the form of a solution suitable for parenteral administration.
Claim 8
Independent Claim
52 words
A method of preparing a product for the treatment of diabetes mellitus or hypoglycaemia, which method comprises bringing an active ingredient selected from amylin, amylin-NH₂, CGRP, functional peptide fragments thereof and conservative variants of the amylin or amylin-NH₂ or CGRP or fragment, into the form of a solution suitable for parenteral administration.
Claim 9
Independent Claim
60 words
A method of preparing a composition for the treatment of diabetes mellitus or hypoglycaemia, which method comprises bringing the active ingredients a) insulin and b) amylin or amylin-NH₂ or CGRP or a functional peptide fragment thereof or a conservative variant of the amylin or amylin- NH₂ or CGRP or fragment, into the form of a solution suitable for parenteral administration.
Claim 10
Independent Claim
60 words
A method of preparing a composition for the treatment of diabetes mellitus or hypoglycaemia, which method comprises bringing the active ingredients a) insulin and b) amylin or amylin-NH₂ or CGRP or a functional peptide fragment thereof or a conservative variant of the amylin or amylin- NH₂ or CGRP or fragment, into the form of a solution suitable for parenteral administration.
Claim 11
Dependent Claim
55 words
Use of a peptide in a method for the preparation of a medicament for treating a mammalian patient for diabetes mellitus or hypoglycaemia, which peptide is amylin or amylin-NH₂ or CGRP or a functional peptide fragment of amylin or amylin-NH₂ or CGRP or a conservative variant of the amylin or amylin-NH₂ or CGRP or fragment.
Claim 12
Dependent Claim
55 words
Use of a peptide in a method for the preparation of a medicament for treating a mammalian patient for diabetes mellitus or hypoglycaemia, which peptide is amylin or amylin-NH₂ or CGRP or a functional peptide fragment of amylin or amylin-NH₂ or CGRP or a conservative variant of the amylin or amylin-NH₂ or CGRP or fragment.
Claim 13
Dependent Claim
15 words
A use as claimed in claim 7, wherein insulin is also combined with the medicament.
Claim 14
Dependent Claim
32 words
A use as claimed in claim 8, wherein the insulin and the amylin or amylin-NH₂ or CGRP (or fragment or variant) are combined in a molar ratio of from 100:1 to 0.1:1.
Claim 15
Dependent Claim
30 words
A use as claimed in claim 8 or claim 9 wherein a composition comprising the insulin and the amylin or amylin-NH₂ or CGRP (or fragment or variant) is administered parenterally.
Claim 16
Dependent Claim
27 words
A composition for treatment of diabetes mellitus or hypoglycaemia comprising a combination of peptide or fragment according to any one of claims 1 to 4 and insulin.
Claim 17
Dependent Claim
31 words
A composition according to claim 11 wherein the insulin and the amylin or amylin-NH₂ or CGRP (or fragment or variant) are combined in a molar ratio of from 100:1 to 0.01:1.
Claim 18
Dependent Claim
23 words
A soluble preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, useful in the treatment of diabetes mellitus or hypoglycaemia.
Claim 19
Dependent Claim
23 words
A soluble preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, useful in the treatment of diabetes mellitus or hypoglycaemia.
Claim 20
Dependent Claim
15 words
The preparation of claim 13 that has been rendered soluble by treatment with formic acid.
Claim 21
Dependent Claim
13 words
The preparation of claim 14 wherein said formic acid is 70% formic acid.
Claim 22
Dependent Claim
15 words
The preparation of claim 13 that has been rendered soluble by treatment with guanidinium hydrochloride.
Claim 23
Dependent Claim
24 words
The preparation of claim 16 wherein said guanidinium hydrochloride is 6.0 M guanidinium hydrochloride in a buffer containing monohydrogen phosphate or sodium dihydrogen phosphate.
Claim 24
Dependent Claim
19 words
The preparation of claim 17 wherein said buffered guanidinium hydrochloride has a final guanidinium hydrochloride concentration of 6.0 M.
Claim 25
Dependent Claim
13 words
The preparation of claim 13 that has been rendered by soluble by ultrasound.
Claim 26
Dependent Claim
28 words
The preparation of claim 13 that has been rendered soluble by dissolution in salts of sodium or ammonium, especially ammonium bicarbonate or carbonate or sodium bicarbonate or carbonate.
Claim 27
Dependent Claim
20 words
The preparation of claim 13 that has been solubilized by treatment with trifluoroacetic acid or acetonitrile, or a mixture thereof.
Claim 28
Dependent Claim
14 words
The preparation of claim 21 wherein said trifluoroacetic acid is about 0.1-1.0% trifluoroacetic acid.
Claim 29
Dependent Claim
16 words
A preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, that is lyophilized.
Claim 30
Dependent Claim
16 words
A preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, that is lyophilized.
Claim 31
Dependent Claim
15 words
A delayed release preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide.
Claim 32
Dependent Claim
15 words
A delayed release preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide.
Claim 33
Dependent Claim
9 words
The preparation of claim 24 in combination with insulin.
Claim 34
Dependent Claim
12 words
The preparation of either of claims 24 or 25 formulated with protamine.
Claim 35
Dependent Claim
14 words
The preparation of any of claims 24 to 26 formulated with a zinc salt.
Claim 36
Dependent Claim
12 words
The preparation of claim 27 wherein said zinc salt is zinc chloride.
Claim 37
Dependent Claim
23 words
A preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, in which the amylin, amylin-amide, or subfragments thereof are crystallized.
Claim 38
Dependent Claim
23 words
A preparation of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, in which the amylin, amylin-amide, or subfragments thereof are crystallized.
Claim 39
Dependent Claim
17 words
The preparation of claim 29 further comprising a zinc salt and a buffer suitable for parenteral administration.
Claim 40
Dependent Claim
12 words
The preparation of claim 30 wherein said zinc salt is zinc chloride.
Claim 41
Dependent Claim
25 words
A suspension of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, formulated with a zinc salt in a buffer suitable for parenteral administration.
Claim 42
Dependent Claim
25 words
A suspension of amylin or amylin-amide, or active subfragment(s) of amylin or amylin-amide, formulated with a zinc salt in a buffer suitable for parenteral administration.
Claim 43
Dependent Claim
12 words
The suspension of claim 32 wherein said zinc salt is zinc chloride.
Claim 44
Dependent Claim
23 words
A crystallized preparation of amylin and divalent zinc cation, in which the crystals have been resuspended in a solution of sodium acetate/sodium chloride.
Claim 45
Dependent Claim
23 words
A crystallized preparation of amylin and divalent zinc cation, in which the crystals have been resuspended in a solution of sodium acetate/sodium chloride.
Claim 46
Dependent Claim
17 words
The preparation of claim 34 wherein said solution has a pH of about 7.2 to about 7.5.
Claim 47
Dependent Claim
16 words
The preparation of any of claims 13 to 35 in which the disulfide bond is intact.
Claim 48
Dependent Claim
17 words
The preparation of any of claims 13 to 35 in which the disulfide bond is not intact.
Claim 49
Independent Claim
30 words
A method for preparing amylin, amylin-amide, or subfragments thereof, comprising dissolution of said amylin, amylin-amide or subfragments thereof in an appropriate denaturing agent and oxidation by an appropriate oxidizing agent.
Claim 50
Independent Claim
30 words
A method for preparing amylin, amylin-amide, or subfragments thereof, comprising dissolution of said amylin, amylin-amide or subfragments thereof in an appropriate denaturing agent and oxidation by an appropriate oxidizing agent.
Claim 51
Dependent Claim
12 words
The method of claim 38 wherein said oxidizing agent is potassium ferricyanide.
Claim 52
Independent Claim
20 words
The method of either of claims 38 and 39 wherein said denaturing agent is selected from guanidinium chloride and urea.
Claim 53
Dependent Claim
42 words
A use of a peptide in a method for monitoring the therapy of diabetes mellitus or hypoglycaemia by determination of the level of peptide in the blood, serum or plasma of a patient undergoing said therapy in which said peptide is amylin.
Claim 54
Dependent Claim
42 words
A use of a peptide in a method for monitoring the therapy of diabetes mellitus or hypoglycaemia by determination of the level of peptide in the blood, serum or plasma of a patient undergoing said therapy in which said peptide is amylin.
Claim 55
Dependent Claim
14 words
A use according to claim 41 wherein said therapy is an islet cell transplant.
Claim 56
Dependent Claim
13 words
A use according to claim 41 wherein said therapy is a pancreatic transplant.
Claim 57
Dependent Claim
15 words
A use according to claim 41 wherein said therapy is an implant of pancreatic tissue.
Claim 58
Dependent Claim
14 words
A use according to claim 41 wherein said therapy is or includes amylin therapy.
Claim 59
Dependent Claim
26 words
A use according to any one of claims 41 to 45 wherein the amylin is a preparation according to any one of claims 13 to 35.
References Cited (Backward Citations)
EP0289287A2
Cited
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