A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00819091Tipo: INTERVENTIONALInicio: 1 de dic de 2008

Traducción no disponible, mostrando original

Resumen

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug

Criterios de exclusión

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance

Intervenciones

drug

BI 1356

5mg orally (po) tablet qd

drug

Placebo

Placebo matching BI 1356 5mg one tablet daily

Ubicaciones

1218.35.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1218.35.54005 Boehringer Ingelheim Investigational Site

Corrientes, Argentina

1218.35.54001 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1218.35.54006 Boehringer Ingelheim Investigational Site

Parque Velez Sarfield, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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