A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

CompletadoFase 3ClinicalTrials.gov

ID: NCT00528879Tipo: INTERVENTIONALInicio: 1 de sept de 2007Fin estimado: 1 de may de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 77 YearsSexo: ALL

Criterios de inclusión

C-peptide ≥1.0 ng/mL
Body mass index ≤45.0 kg/m\^2
Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
Serum creatinine level \<1.50 mg/dL for men or \<1.40 mg/dL for women.

Criterios de exclusión

Aspartate aminotransferase and/or alanine aminotransferase level \>3.0 times the upper limit of normal
Serum total bilirubin level \>2 mg/dL
Creatinine kinase level \>3 times upper limit of normal
Symptoms of severely uncontrolled diabetes
Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

Intervenciones

drug

Dapagliflozin

Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks

drug

Placebo

Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks

drug

Metformin

Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Ciudad Auton., Buenos Aires, Argentina

Local Institution

Ciudad Auton, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Zárate, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Villa Carlos Paz, Córdoba Province, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorBristol-Myers Squibb

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