# US 2019/0314464 A1 · Novel method for treating diabetes

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- Number: US 2019/0314464 A1
- Document ID: US20190314464A1
- Status: Published application
- Kind: A1
- Application number: 16/470,117
- Filed: 2017-06-19
- Published: 2019-10-17
- Earliest claimed: 2016-12-15
- Assignees: Talengen International Limited
- Applicants: Talengen International Limited
- Inventors: Jinan LI
- Web page: https://patentgrep.com/patent/US20190314464A1

## CPC

- A61K 38/484: {Plasmin (3.4.21.7)}
- A61K 38/43: Enzymes; Proenzymes; Derivatives thereof
- A61K 38/48: acting on peptide bonds (3.4)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/50: for increasing or potentiating the activity of insulin
- C12Y 304/21007: Plasmin (3.4.21.7), i.e. fibrinolysin
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Y: ENZYMES

## Abstract

The present invention relates to a novel method for treating diabetes mellitus, comprising administering an effective amount of plasminogen to a diabetic subject; furthermore, the present invention relates to a medicament for treating diabetes mellitus.

## Claims

### Claim at position 1

1-69. (canceled)

### Claim 70

A method for treating diabetes mellitus, comprising administering an effective amount of plasminogen to the subject to reduce blood glucose in the diabetic subject.

### Claim 71 (depends on 70)

The method of claim 70, wherein the blood glucose is selected from one or more of: a serum glucose level, a serum fructosamine level, and a serum glycated hemoglobin level.

### Claim 72 (depends on 71)

The method of claim 71, wherein the blood glucose is a serum glucose level.

### Claim 73 (depends on 70)

The method of claim 70, wherein the diabetes mellitus is T1DM or T2DM.

### Claim 74 (depends on 70)

The method of claim 70, wherein the blood glucose is postprandial blood glucose.

### Claim 75 (depends on 74)

The method of claim 74, wherein the plasminogen is administered 30 minutes to 1.5 hours before the subject has a meal.

### Claim 76 (depends on 70)

The method of claim 70, comprising improving the glucose tolerance in the diabetic subject by administering an effective amount of plasminogen to the subject.

### Claim 77 (depends on 76)

The method of claim 76, wherein the diabetes mellitus is T2DM.

### Claim 78

A method for promoting secretion of insulin in a diabetic subject, comprising administering an effective amount of plasminogen to the subject.

### Claim 79 (depends on 78)

The method of claim 78, wherein the plasminogen further promotes expression of insulin in the diabetic subject.

### Claim 80 (depends on 78)

The method of claim 78, wherein the diabetes mellitus is T1DM or T2DM.

### Claim 81 (depends on 78)

The method of claim 78, wherein the plasminogen promotes secretion of insulin in the diabetic subject after eating.

### Claim 82 (depends on 78)

The method of claim 78, wherein the plasminogen returns blood glucose to a normal or nearly normal level by promoting secretion of insulin in response to a stimulation of elevated blood glucose in the diabetic subject.

### Claim 83 (depends on 78)

The method of claim 78, wherein the plasminogen achieves a return to a normal or nearly normal level of blood glucose in the subject by reducing expression and/or secretion of glucagon in the subject while promoting the expression and/or secretion of insulin.

### Claim 84

A method for reducing secretion of glucagon in a diabetic subject, comprising administering an effective amount of plasminogen to the subject.

### Claim 85 (depends on 84)

The method of claim 84, wherein the plasminogen further reduces expression of glucagon in the diabetic subject.

### Claim 86 (depends on 84)

The method of claim 84, wherein the diabetes mellitus is T1DM or T2DM.

### Claim 87 (depends on 84)

The method of claim 84, wherein the plasminogen reduces secretion of glucagon in the diabetic subject after eating.

### Claim 88 (depends on 84)

The method of claim 84, wherein the plasminogen reduces secretion of glucagon in the diabetic subject in a fasted state.

### Claim 89 (depends on 84)

The method of claim 84, wherein the plasminogen returns blood glucose to a normal or nearly normal level by reducing secretion of glucagon in the diabetic subject in an elevated blood glucose state.

### Claim 90 (depends on 70)

The method of claim 70, wherein the plasminogen promotes repair of a pancreatic islet cell injury in a diabetic subject, wherein the pancreatic islet cell injury is an injury selected from a group consisting of:
injured insulin synthesis and secretion function of pancreatic islet β cells,
collagen deposition in the pancreatic islet,
pancreatic islet fibrosis,
pancreatic islet cell apoptosis,
disordered balance between secretion of glucagon and of insulin in the pancreatic islet,
failed adaptation of levels of glucagon and insulin secreted by the pancreatic islet to a blood glucose level in the subject, and
inflammation in the pancreatic islet.

### Claim 91 (depends on 90)

The method of claim 90, wherein the plasminogen promotes expression of insulin receptor substrate 2 (IRS-2), cytokine TNF-α, and/or multi-directional nuclear transcription factor NF-κB in the subject.

### Claim 92 (depends on 90)

The method of claim 90, wherein the normal balance between secretion of glucagon and of insulin in the pancreatic islet is repaired.

### Claim 93 (depends on 70)

The method of claim 70, wherein the plasminogen is administered in combination with one or more other drugs or therapies.

### Claim 94 (depends on 93)

The method of claim 93, wherein the plasminogen is administered in combination with one or more drugs selected from anti-diabetic drugs, drugs against cardiovascular and cerebrovascular diseases, anti-thrombotic drugs, anti-hypertensive drugs, antilipemic drugs, anticoagulant drugs, and anti-infective drugs.

### Claim 95 (depends on 70)

The method of claim 70, wherein the plasminogen has at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% sequence identity with SEQ ID No. 2, and still has the plasminogen activity.

### Claim 96 (depends on 70)

The method of claim 70, wherein the plasminogen is a protein that comprises a plasminogen active fragment and still has the plasminogen activity.

### Claim 97 (depends on 70)

The method of claim 70, wherein the plasminogen is selected from Glu-plasminogen, Lys-plasminogen, mini-plasminogen, micro-plasminogen, delta-plasminogen or their variants that retain the plasminogen activity.

### Claim 98 (depends on 70)

The method of claim 70, wherein the plasminogen is a natural or synthetic human plasminogen, or a variant or fragment thereof that still retains the plasminogen activity.

### Claim 99 (depends on 70)

The method of claim 70, wherein the plasminogen is administered to the subject at a dosage of 1-100 mg/kg, 1-50 mg/kg, or 1-10 mg/kg, daily, every other day, or weekly.

### Claim 100 (depends on 99)

The method of claim 99, wherein the dosage of the plasminogen is preferably repeated at least once.

### Claim 101 (depends on 99)

The method of claim 99, wherein the plasminogen is preferably administered at least daily.