The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
Glycosylated haemoglobin (HbA1c) of \>= 7.0% and \<=10% for patients on background therapy or HbA1c \>= 7.0% and \<= 9.0% for drug naive patients
Age \>= 18 years
Body Mass index \<= 45 at Visit 1
Signed and dated informed consent
High cardiovascular risk

Criterios de exclusión

Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
Planned cardiac surgery or angioplasty within 3 months
Impaired renal function, defined as Glomerular Filtration Rate \<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
Contraindications to background therapy according to the local label
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
Pre-menopausal women (last menstruation \<+ 1 year prior to informed consent) who:
are nursing or pregnant or
are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
Participation in another trial with an investigational drug within 30 days prior to informed consent
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent

Intervenciones

drug

BI 10773 low dose

BI 10773 tablets once daily

drug

Placebo BI 10773 high dose

Placebo tablets identical to BI 10773

drug

BI 10773 high dose

BI 10773 tablets once daily

drug

Placebo BI 10773 low dose

Placebo tablets identical to BI 10773

drug

Placebo BI 10773 low dose

Placebo tablets identical to BI 10773

drug

Placebo BI 10773 high dose

Placebo tablets identical to BI 10773

Ubicaciones

1245.25.54012 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

1245.25.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.25.54006 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.25.54013 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.25.54002 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1245.25.54003 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1245.25.54010 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1245.25.54011 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1245.25.54005 Boehringer Ingelheim Investigational Site

Parque Velez Sarfield, Argentina

1245.25.54008 Boehringer Ingelheim Investigational Site

Rosario, Argentina

1245.25.54009 Boehringer Ingelheim Investigational Site

Rosario, Argentina

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

BI 10773 low dose

Placebo BI 10773 high dose

BI 10773 high dose

Placebo BI 10773 low dose

Placebo BI 10773 low dose

Placebo BI 10773 high dose

Ubicaciones

1245.25.54012 Boehringer Ingelheim Investigational Site

1245.25.54001 Boehringer Ingelheim Investigational Site

1245.25.54006 Boehringer Ingelheim Investigational Site

1245.25.54013 Boehringer Ingelheim Investigational Site

1245.25.54002 Boehringer Ingelheim Investigational Site

1245.25.54003 Boehringer Ingelheim Investigational Site

1245.25.54010 Boehringer Ingelheim Investigational Site

1245.25.54011 Boehringer Ingelheim Investigational Site

1245.25.54005 Boehringer Ingelheim Investigational Site

1245.25.54008 Boehringer Ingelheim Investigational Site

1245.25.54009 Boehringer Ingelheim Investigational Site

Patrocinadores