A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes

TerminadoFase 2ClinicalTrials.gov

ID: NCT00425919Tipo: INTERVENTIONALInicio: 1 de ene de 2007Fin estimado: 1 de oct de 2007

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose (blood sugar) levels and is safe in treating people with type 2 diabetes.

Descripción detallada

The objectives of the study are to identify doses of PPM-204 that are therapeutically effective and well tolerated in improving glycemic control over 24 weeks of treatment in subjects with type 2 diabetes mellitus (T2DM).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Men and women of non-childbearing potential, 18 to 70 years old
Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication
BMI \> 23 and \< 43
For subjects currently treated with 1 antidiabetic medication: HbA1c is greater than or equal to 6.8% and less than or equal to 8.5%.
For subjects not currently treated with antidiabetic medications: HbA1c is greater than or equal to 7.2% and less than or equal to 9.0%

Criterios de exclusión

Subjects requiring insulin therapy
Subjects currently receiving 2 or more oral antidiabetic medications
Subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit
Subjects receiving warfarin
Subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit
Significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)

Intervenciones

drug

PPM-204

Ubicaciones

Buenos Aires, Argentina

Corrientes, Argentina

La Plata, Argentina

Mar Del Plata Pcia de Bs. As, Argentina

Ramos Mejia, Pcia de Bs., Argentina

Patrocinadores

PrincipalWyeth is now a wholly owned subsidiary of Pfizer

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