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Pharmaceutical composition, methods for treating and uses thereof

a technology of pharmaceutical compositions and compositions, applied in the field of pharmaceutical compositions, can solve the problems of affecting the treatment effect, so as to improve the glycemic control, prevent delay or treat the treatment, and slow the progression of metabolic disorders

Inactive Publication Date: 2012-08-02
BOEHRINGER INGELHEIM INT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a new method for preventing, slowing, delaying, or treating metabolic disorders such as type 2 diabetes mellitus, overweight, obesity, and complications of diabetes mellitus. This is achieved by administering an SGLT2 inhibitor to patients in need of such treatment. The invention also provides a new method for reducing body weight and body fat in patients. The use of an SGLT2 inhibitor is independent of insulin, which helps to maintain the functionality of pancreatic beta cells and improve their differentiation status. Overall, the invention offers new possibilities for the treatment and prevention of metabolic disorders and their associated complications.

Problems solved by technology

In addition, the presence of type 2 diabetes is associated with a two to five fold increase in cardiovascular disease risk.
In addition, even in patients within the intensive treatment arm glycemic control deteriorated significantly over time and this was attributed to deterioration of β-cell function.
Therefore many patients with type 2 diabetes remain inadequately treated, partly because of limitations in long term efficacy, tolerability and dosing inconvenience of existing antihyperglycemic therapies.
The high incidence of therapeutic failure is a major contributor to the high rate of long-term hyperglycemia-associated complications or chronic damages (including micro- and macrovascular complications such as e.g. diabetic nephrophathy, retinopathy or neuropathy, or cardiovascular complications) in patients with type 2 diabetes.

Method used

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  • Pharmaceutical composition, methods for treating and uses thereof
  • Pharmaceutical composition, methods for treating and uses thereof
  • Pharmaceutical composition, methods for treating and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 10a

Prevention of NODAT and / or PTMS, and NODAT / PTMS Associated Complications

[0294]Treatment of patients after organ transplantation with the pharmaceutical composition according to the invention prevents the development of NODAT and / or PTMS, and associated complications. The efficacy of the treatment can be investigated in a comparative clinical study in which patients before or immediately after transplantation are treated over a lengthy period (e.g. 1-5 years) with either a pharmaceutical composition according to this intervention or with a placebo or with a non-drug therapy or other medicaments. During and at the end of the therapy, the incidence of NODAT, PTMS, micro- and macrovascular complications, graft rejection, infection and death will be assessed. A significant reduction in the number of patients experiencing these complications demonstrates the efficacy in preventing development of NODAT, PTMS, and associated complications.

example 10b

Treatment of NODAT and / or PTMS with Prevention, Delay or Reduction of Associated Complications

[0295]Treatment of patients with NODAT and / or PTMS with the pharmaceutical composition according to the invention prevents, delays or reduces the development of NODAT / PTMS associated complications. The efficacy of the treatment can be investigated in a comparative clinical study in which patients with NODAT and / or PTMS are treated over a lengthy period (e.g. 1-5 years) with either a pharmaceutical composition according to this intervention or with a placebo or with a non-drug therapy or other medicaments. During and at the end of the therapy, the incidence of micro- and macrovascular complications, graft rejection, infection and death will be assessed. A significant reduction in the number of patients experiencing these complications demonstrates the efficacy in preventing, delaying or reducing the development of NODAT and / or PTMS associated complications.

example 11a

Treatment of Gestational Diabetes

[0296]In clinical studies running for a shorter period (e.g. 2-4 weeks) the success of the treatment is checked by determining the fasting glucose values and / or the glucose values after a meal or after a loading test (oral glucose tolerance test or food tolerance test after a defined meal) at the end of the therapeutic period of the study and comparing them with the values before the start of the study and / or with those of a placebo group. In addition, the fructosamine value can be determined before and after treatment and compared with the initial value and / or a placebo value. A significant fall in the fasting or non-fasting glucose levels demonstrates the pharmaceutical composition according to the invention.

[0297]In longer-running studies (12 weeks or more) the success of the treatment is checked by determining the HbA1c value (compared with initial value and placebo group). A significant change in the HbA1c value compared with the starting value ...

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PUM

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Abstract

The invention relates to the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia using a SGLT-2 inhibitor. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.

Description

[0001]This application claims benefit from U.S. Provisional Application No. 61 / 152,318, filed on Feb. 13, 2009, the content of which is incorporated herein in its entirety.TECHNICAL FIELD OF THE INVENTION[0002]The invention relates to a pharmaceutical composition comprising an SGLT2-inhibitor as described hereinafter which is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance, impaired fasting blood glucose and hyperglycemia inter alia.[0003]Furthermore the invention relates to methods[0004]for preventing, slowing progression of, delaying, or treating a metabolic disorder;[0005]for improving glycemic control and / or for reducing of fasting plasma glucose, of postprandial plasma glucose and / or of glycosylated hemoglobin HbA1c;[0006]for preventing, slowing, delaying or reversing progression from impaired glucose tolerance, impaired fasting blood glucose, insulin resistance and / or...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/70A61K31/7004A61P3/10A61P3/04A61P3/00A61P3/08A61P27/12A61P9/00A61P27/02A61P13/12A61P25/00A61P9/10A61P9/04A61P9/06A61P1/18A61K31/7048
CPCA61K31/7034A61K31/7048A61P1/18A61P11/00A61P13/12A61P19/06A61P25/00A61P27/02A61P27/12A61P3/00A61P3/04A61P3/06A61P3/08A61P37/06A61P43/00A61P5/50A61P9/00A61P9/04A61P9/06A61P9/08A61P9/10A61P3/10A61K9/0019A61K47/26A61K9/2018A61K9/4866A61K9/2027A61K9/0031A61K9/02
Inventor EICKELMANN, PETERMARK, MICHAELSEMAN, LEO JOHNTHOMAS, LEOBROEDL, ULIGREMPLER, ROLF
Owner BOEHRINGER INGELHEIM INT GMBH
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