A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment

CompletadoFase 3ClinicalTrials.gov

ID: NCT01167881Tipo: INTERVENTIONALInicio: 1 de ago de 2010Fin estimado: 1 de ago de 2015

Traducción no disponible, mostrando original

Resumen

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis typ 2 diabetes mellitus
Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
years or more
BMI equal or less than 45Kg/m2

Criterios de exclusión

Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
Indication of liver disease
Moderate to severe renal impairment
Bariatric surgery within past 2 years
Medical history of cancer or treatment for cancer within last 5 years
Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
Contraindications hypersensitivity to concomitant drugs
Treatment with anti-obesity drugs

Intervenciones

drug

BI 10773

Medium dose once daily

drug

Glimepiride

1-4 mg once daily

drug

Placebo

Placebo matching BI 10773

drug

Placebo

Placebo matching Glimepiride

Ubicaciones

1245.28.54010 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

1245.28.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.28.54002 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1245.28.54003 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

ColaboradorEli Lilly and Company

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