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 of patients, so as to improve the treatment effect, prevent the progression of metabolic disorders, delay or treat the treatment of metabolic disorders, and improve the effect of glycemic control

Inactive Publication Date: 2011-02-24
BOEHRINGER INGELHEIM INT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0039]Within the scope of the present invention it has now surprisingly been found that a pharmaceutical composition comprising a SGLT2 inhibitor and a DPP IV inhibitor and a third antidiabetic agent selected from the group G3 as defined hereinafter can advantageously be used for preventing, slowing progr

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

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 8

Prevention of Micro- or Macrovascular Complications

[0351]The treatment of type 2 diabetes or pre-diabetes patients with a pharmaceutical composition according to the invention prevents or reduces or reduces the risk of developing microvascular complications (e.g. diabetic neuropathy, diabetic retinopathy, diabetic nephropathy, diabetic foot, diabetic ulcer) or macrovascular complications (e.g. myocardial infarct, acute coronary syndrome, unstable angina pectoris, stable angina pectoris, stroke, peripheral arterial occlusive disease, cardiomyopathy, heart failure, heart rhythm disorders, vascular restenosis). Type 2 diabetes or patients with pre-diabetes are treated long-term, e.g. for 1-6 years, with a pharmaceutical composition according to the invention or a combination of active ingredients according to the invention and compared with patients who have been treated with other antidiabetic medicaments or with placebo. Evidence of the therapeutic success compared with patients who ...

example 9

Treatment of Metabolic Syndrome

[0352]The efficacy of a pharmaceutical composition according to the invention can be tested in clinical studies with varying run times (e.g. 12 weeks to 6 years) by determining the fasting glucose or non-fasting glucose (e.g. after a meal or a loading test with oGTT or a defined meal) or the HbA1c value. A significant fall in these glucose values or HbA1c values during or at the end of the study, compared with the initial value or compared with a placebo group, or a group given a different therapy, proves the efficacy of an active ingredient or combination of active ingredients in the treatment of Metabolic Syndrome. Examples of this are a reduction in systolic and / or diastolic blood pressure, a lowering of the plasma triglycerides, a reduction in total or LDL cholesterol, an increase in HDL cholesterol or a reduction in weight, either compared with the starting value at the beginning of the study or in comparison with a group of patients treated with ...

example 10a

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

[0353]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.

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Abstract

The invention relates to a pharmaceutical composition according to the claim 1 comprising an SGLT2 inhibitor, a DPPIV inhibitor and a third antidiabetic agent 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 and hyperglycemia. 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 / 152,302, 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, a DPPIV inhibitor and a third antidiabetic agent selected from the group G3 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...

Claims

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Application Information

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IPC IPC(8): A61K31/7034A61P3/10A61P3/04A61P9/10A61P9/00
CPCA61K31/00A61K31/7048A61K31/198A61K31/341A61K31/351A61K31/39A61K31/403A61K31/4439A61K31/70A61K31/7004A61K31/7008A61K45/06A61K31/155A61K31/522A61K2300/00A61P13/04A61P13/12A61P19/06A61P3/00A61P3/04A61P3/12A61P3/06A61P3/08A61P43/00A61P9/00A61P9/10A61P3/10
Inventor EICKELMANN, PETERMARK, MICHAELSEMAN, LEO JOHNTHOMAS, LEOBROEDL, ULIGREMPLER, ROLF
Owner BOEHRINGER INGELHEIM INT GMBH
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