18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone

CompletadoFase 3ClinicalTrials.gov

ID: NCT00666458Tipo: INTERVENTIONALInicio: 1 de abr de 2008Fin estimado: 1 de mar de 2009

Traducción no disponible, mostrando original

Resumen

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosed with type 2 diabetes
Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks

Criterios de exclusión

Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
Insulin therapy within one year
Previous treatment with DPP-4 inhibitor

Intervenciones

drug

saxagliptin

tablet, per oral, once daily

drug

sitagliptin

capsule, per oral, once daily

Ubicaciones

Research Site

Buenos Aires, Buenos Aires, Argentina

Research Site

Lanús, Buenos Aires, Argentina

Research Site

Mar del Plata, Buenos Aires, Argentina

Research Site

Santa Fe, Santa Fe Province, Argentina

Research Site

Caba, Argentina

Research Site

Capital Federal, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorBristol-Myers Squibb

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