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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00683878Tipo: INTERVENTIONALInicio: 1 de jul de 2008Fin estimado: 1 de jun de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
Body Mass Index ≤ 45.0 kg/m²

Criterios de exclusión

AST and /or ALT \> 2.5 times the upper limit of normal
Serum total bilirubin \> 2 mg/dL (34.2 µmol/L)
Creatinine kinase \> 3.0 times the upper limit of normal
Symptoms of severely uncontrolled diabetes
Serum creatinine ≥ 2.0 mg/dL
Calculated Cr-Clearance \< 50 ml/min (calculated by Cockroft-Gault formula)
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Intervenciones

drug

Dapagliflozin

Tablets, Oral, 5.0 mg, once daily, up to 48 weeks

drug

Dapagliflozin

Tablets, Oral, 10.0 mg, once daily, up to 48 weeks

drug

Placebo matching Dapagliflozin

Tablets, Oral, 0 mg, once daily, up to 48 weeks

drug

Thiazolidinedione (Pioglitazone)

Tablets, ≥ 30 mg, Once daily, up to 48 weeks

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad Auton, Buenos Aires, Argentina

Local Institution

Zárate, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorAstra Zeneca, Bristol-Myers Squibb

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