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Combination therapy for the treatment of diabetes

a combination therapy and diabetes technology, applied in the field of cotherapy and methods for the treatment and prevention of glucose-related disorders, can solve problems such as glucose build-up in the blood

Inactive Publication Date: 2011-01-13
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0031]The present invention is directed to methods of co-therapy for the treatment and prevention of glucose-related disorders, said methods comprising administering to a sub

Problems solved by technology

People with diabetes either don't produce insulin, produce too little insulin or do not respond to insulin, resulting in the build up of glucose in the blood.

Method used

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  • Combination therapy for the treatment of diabetes
  • Combination therapy for the treatment of diabetes
  • Combination therapy for the treatment of diabetes

Examples

Experimental program
Comparison scheme
Effect test

example 1

In Vivo Mouse Study

[0284]Male C57BL / 6 mice (total of 100 mice) were fed with a high fat diet from the age of 3 weeks to 6 weeks (total 3 weeks). After 3 weeks on a high fat diet, all the mice received a single-dose ip injection of Steptozotocin (STZ) (100 mg / kg, in 0.05 mol / L citric acid, pH4.5, 10 mg / ml). All the mice were then kept on a high fat diet for another 3 weeks. Those mice with fasted blood glucose levels >7 mM and <15 mM were selected for the study.

[0285]At the start of the pre-dose period, each mouse was assigned a predose number, which was indicated on its cage card. After assignment to dosage groups, each mouse was assigned a unique study identification number (which will be indicated on its cage card) and identified by permanent marker on its tail. Mice were housed 5 mice per cage in stainless steel cages. The study room was maintained on a 12-hour light / dark cycle (light / dark cycle may be interrupted for study-related activities), within a temperature range of 64° F...

example 2

In Vivo Mouse Study

[0293]Male ob / ob mice (8-week old, ˜50 g) were housed 2 mice per cage in a temperature-controlled room with 12-hour light / dark cycle. The mice were allowed ad libitum access to water and chow (commercially supplied diet). Mice were grouped into 6 test groups based on their body weight and fed blood glucose levels, as noted in Table 2, below.

TABLE 2Mouse Treatment groupsGroupTreatment1Vehicle (0.5% Methocel) 1 ml / 100 g, P.O.2Compound of formula (I-X) @ 1.0 mpk: 1 ml / 100 g, P.O.3Compound of formula (I-X) @ 10.0 mpk: 1 ml / 100 g, P.O.4Metformin HCl: 250 mpk: 1 ml / 100 g, P.O.5Compound of formula (I-X) @ 1 mpkMetformin HCl: 250 mpk, 1 ml / 100 g, P.O.6Compound of formula (I-X) @ 10 mpkMetformin HCl: 250 mpk, 1 ml / 100 g, P.O.

Study Design:

[0294]On the first morning, the mice were grouped as noted above and fed glucose. The mice were then dosed with vehicle or test compound(s) via gavage at 4:00 pm each day for 22 days q.d. The compound of formula (I-X) was dosed at 1 mg / kg ...

example 3

Pharmaceutical Composition

Combination of Metformin Hydrochloride and the Compound of Formula (I-X)

[0299]A pharmaceutical composition comprising metformin hydrochloride and the compound of formula (I-X) was prepared as follows, with Table 4, below listing the components in the formulation. Metformin HCl was purchased as commercially available Drug Substance (DS) from Solmag S. P. A Mulazzano (Via Della Vittoria 89, 26837 Cassino d'Alberi, Mulazzano, Italy).

TABLE 4Combination Tablet Formulationmg / Quanity / DescriptionFunctiontablet% w / wBatch (g)Intragranular AdditionsCompound of FormulaDrug200.014.69132.2(I-X)Substance-1Metformin HClDrug1000.073.46660.8Substance-2Microcrystalline CelluloseFiller59.24.3539.1Povidone (K29 / 32)1Binder54.504.0036.0Croscarmellose sodiumDisintegrant40.803.0027.3Water2NAN / AExtragranular AdditionsMagnesium Stearate, 2257Lubricant6.80.504.5Totals100.01361.3100.0899.61Added as 6% solids in solution2Not in final formulation

[0300]Metformin hydrochloride, the compoun...

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Abstract

The present invention is directed to co-therapy and methods for the treatment and prevention of glucose-related disorders such as Type 2 diabetes mellitus and Syndrome X. The present invention is further directed to pharmaceutical compositions for the co-therapy and methods described herein.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application 61 / 223,881, filed on Jul. 8, 2009, which is incorporated by reference herein in its entirety.FIELD OF THE INVENTION[0002]The present invention is directed to co-therapy and methods for the treatment and prevention of glucose-related disorders such as Type 2 diabetes mellitus and Syndrome X. The present invention is further directed to pharmaceutical compositions for the co-therapy and methods described herein.BACKGROUND OF THE INVENTION[0003]Diabetes mellitus is a medical term for the presence of elevated blood glucose. People with diabetes either don't produce insulin, produce too little insulin or do not respond to insulin, resulting in the build up of glucose in the blood. The most common form of diabetes is Type 2 diabetes, once referred to as adult onset diabetes or non-insulin dependent diabetes (NIDDM), which may account for >90% of diabetes in adults. However, ...

Claims

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Application Information

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IPC IPC(8): A61K31/7064A61K31/7042A61P3/10A61P43/00A61P5/50A61P3/00A61P3/06A61P3/04A61P9/10A61P9/12
CPCA61K31/155A61K31/7034A61K31/7042A61K2300/00A61K31/381A61K31/4436A61P13/12A61P17/02A61P25/00A61P27/02A61P3/00A61P3/04A61P3/06A61P3/08A61P43/00A61P5/50A61P9/10A61P9/12A61P3/10A61K47/38A61K45/06A61K2121/00
Inventor LIANG, YINRYAN, JOHNWOLDU, ABRAHAM B.WU, LISA
Owner JANSSEN PHARMA NV
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