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Pharmaceutical composition, methods for treating and uses thereof

a technology of pharmaceutical compositions and sglt2 inhibitors, applied in the field of sglt2 inhibitors, can solve the problems of reducing the capacity of the kidneys to excrete waste products

Inactive Publication Date: 2014-10-23
BOEHRINGER INGELHEIM INT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent is about a new treatment for diabetes that targets a protein called SGLT2. The invention provides pharmaceutical compositions and methods for making the medication. The compounds can be made using synthetic methods and are described in various patents. The medication can be in the form of a salt or solvate, such as a hydrate or alcohol adduct. The patent also covers combinations of the SGLT-2 inhibitor with other active substances for use in treating diabetes. Overall, the invention provides improved effectiveness, dosage strength, dosage frequency, and pharmacodynamic and pharmacokinetic properties for the treatment of diabetes.

Problems solved by technology

Higher levels of creatinine indicate a lower glomerular filtration rate and as a result a decreased capability of the kidneys to excrete waste products.

Method used

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  • Pharmaceutical composition, methods for treating and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

Empagliflozin in Patients with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment (RI)

[0351]A Phase III trial investigated the efficacy and safety of empagliflozin (EMPA) as add-on to existing therapy for 52 weeks in patients with T2DM and RI. Patients with mild RI (eGFR [MDRD equation]≧60 to 2) received EMPA 10 or 25 mg qd or placebo (PBO). Patients with moderate RI (eGFR≧30 to 2) received EMPA 25 mg qd or PBO. Patients with severe RI (eGFR≧15 to 2) received EMPA 25 mg qd or PBO.

[0352]In patients with type 2 diabetes and mild renal impairment, treatment with empagliflozin 10 and 25 mg at week 52 resulted in a small decrease in eGFR. However, mean eGFR increased to a value slightly above baseline at the 3-week follow up visit in the empagliflozin treatment groups; in contrast, in the placebo group, mean eGFR further decreased (Table 1A).

TABLE 1ADescriptive statistics for eGFR over timein patients with mild renal impairmentPlaceboEmpa 10 mgEmpa 25 mgNumber of patients  32 (100.0)  ...

example 2

Empagliflozin in Hypertensive Patients with Type 2 Diabetes Mellitus (T2DM)

[0355]A Phase III trial investigated the efficacy and safety of empagliflozin (EMPA) administered orally, once daily over 12 weeks in hypertensive patients with T2DM (EMPA 10 or 25 mg, placebo (PBO)). Patients with a systolic blood pressure (SBP) of 130 to 159 mmHg and a diastolic blood pressure (DSP) of 80 to 99 mmHg were included in the trial.

[0356]Treatment with empagliflozin 10 and 25 mg at week 12 resulted in a small decrease in eGFR. However, mean eGFR increased to a value slightly above baseline at the 2-week follow up visit in the empagliflozin treatment groups; in contrast, in the placebo group, mean eGFR remained slightly below baseline (Table 2).

TABLE 2Descriptive statistics for eGFR (MDRD) over timePlaceboEmpa 10 mgEmpa 25 mgBaseline eGFRN* (%)238 (100)241 (100)244 (100)Mean (SD)84.47 (17.06)83.01 (16.43)83.97 (17.85)[mL / min / 1.73 m2]Last value ontreatment eGFRN* (%) 237 (99.6) 238 (98.8) 240 (98.4...

example 3

Empagliflozin in Patients with Type 2 Diabetes Mellitus (T2DM) Receiving Treatment with Basal Insulin

[0357]A Phase IIb trial investigated the efficacy and safety of empagliflozin (EMPA 10 or 25 mg, placebo (PBO)) administered orally, once daily over 78 weeks in patients with T2DM receiving treatment with basal insulin (glargine, detemir, or NPH insulin only).

[0358]Treatment with empagliflozin 10 and 25 mg resulted in a small decrease in eGFR. However, mean eGFR increased to a value slightly below baseline at the 4-week follow up visit in the empagliflozin treatment groups; in contrast, in the placebo group, mean eGFR further slightly decreased (Table 3).

TABLE 3Descriptive statistics for eGFR (MDRD) over timePlaceboEmpa 10 mgEmpa 25 mgNumber of patients, 170 (100.0) 169 (100.0) 155 (100.0)N (%)Baseline eGFRN1 (%) 170 (100.0) 169 (100.0) 155 (100.0)Mean (SD)83.89 (22.73)85.01 (23.63)82.88 (25.46)Week 18 eGFRN1 (%) 134 (78.8) 133 (78.7) 113 (72.9)Mean (SD)80.07 (20.15)80.37 (23.03)79.1...

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Abstract

The present invention relates to certain SGLT-2 inhibitors for treating, preventing, protecting against and / or delaying the progression of chronic kidney disease in patients, for example patients with prediabetes, type 1 or type 2 diabetes mellitus.

Description

TECHNICAL FIELD OF THE INVENTION[0001]The present invention relates to certain SGLT-2 inhibitors for treating, preventing, protecting against and / or delaying the progression of chronic kidney disease in patients, for example patients with prediabetes, type 1 or type 2 diabetes mellitus.BACKGROUND OF THE INVENTION[0002]Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and chronic kidney disease is often diagnosed as a result of screening of people known to be at risk of kidney problems.[0003]Chronic kidney disease may be identified by a blood test, for example for creatinine. Higher levels of creatinine indicate a lower glomerular filtration rate and as a result a decreased capability of the kidneys to excrete waste products.[0004]CKD has been classified into 5 stages, where stage 1 is kidney damage with normal GFR (mL / min / 1.73 m2) of ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/7048A61K45/06
CPCA61K45/06A61K31/7048A61K31/155A61K31/522A61K38/28A61K9/2018A61K9/2866A61P13/02A61P13/12A61P43/00A61P3/10A61K2300/00
Inventor BROEDL, ULI CHRISTIANJOHANSEN, ODD-ERIKMAYOUX, ERIC WILLIAMSSOLEYMANLOU, NIMAVON EYNATTEN, MAXIMILIANWOERLE, HANS-JUERGENCHERNEY, DAVID Z.I.PERKINS, BRUCE A.
Owner BOEHRINGER INGELHEIM INT GMBH
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