A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

TerminadoFase 3ClinicalTrials.gov

ID: NCT00850239Tipo: INTERVENTIONALInicio: 1 de may de 2009Fin estimado: 1 de dic de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
Age 18 to 85 years, inclusive.
Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (\> 0.8 ng/mL; \> 281 pmol/L) at screening (Visit 1)

Criterios de exclusión

Type 1 diabetes mellitus

Intervenciones

drug

dutogliptin

400 mg

drug

placebo

Ubicaciones

Phenomix Investigational Site 401

Buenos Aires, Argentina

Phenomix Investigational Site 402

Buenos Aires, Argentina

Phenomix Investigational Site 404

Buenos Aires, Argentina

Phenomix Investigational Site 405

Buenos Aires, Argentina

Phenomix Investigational Site 406

Buenos Aires, Argentina

Phenomix Investigational Site 407

Buenos Aires, Argentina

Phenomix Investigational Site 408

Buenos Aires, Argentina

Phenomix Investigational Site 409

Buenos Aires, Argentina

Phenomix Investigational Site 411

Buenos Aires, Argentina

Phenomix Investigational Site 403

Corrientes, Argentina

Phenomix Investigational Site 410

Mendoza, Argentina

Phenomix Investigational Site 400

Rosario, Argentina

Patrocinadores

PrincipalPhenomix

ColaboradorForest Laboratories

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