Resumen

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably\* \>/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
Glycosylated haemoglobin A1 (HbA1c) \>/= 7.0 and \</= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
Age \>/= 18 and \</= 80 years at Visit 1a (screening)
BMI (Body Mass Index) \</= 40 kg/m2 at Visit 1a (screening)
Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation \*Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Criterios de exclusión

Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
Renal failure or renal impairment (serum creatinine \>/= 1.5 mg/dl) as determined at Visit 1a
Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
Treatment with insulin within 3 months prior to the date of informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
Pre-menopausal women (last menstruation \</= 1 year prior to the date of 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 periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
Dehydration (as confirmed by the Investigators clinical opinion)
Current acute or chronic metabolic acidosis

Ubicaciones

1218.18.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1218.18.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1218.18.54004 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1218.18.54005 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1218.18.54010 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1218.18.54014 Boehringer Ingelheim Investigational Site

Corrientes, Argentina

1218.18.54009 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1218.18.54013 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1218.18.54003 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1218.18.54012 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1218.18.54011 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

1218.18.54015 Boehringer Ingelheim Investigational Site

Parque Velez Sarfield, Argentina

1218.18.54006 Boehringer Ingelheim Investigational Site

Rosario, Argentina

1218.18.54007 Boehringer Ingelheim Investigational Site

Salta, Argentina

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

linagliptin

placebo

Ubicaciones

1218.18.54001 Boehringer Ingelheim Investigational Site

1218.18.54002 Boehringer Ingelheim Investigational Site

1218.18.54004 Boehringer Ingelheim Investigational Site

1218.18.54005 Boehringer Ingelheim Investigational Site

1218.18.54010 Boehringer Ingelheim Investigational Site

1218.18.54014 Boehringer Ingelheim Investigational Site

1218.18.54009 Boehringer Ingelheim Investigational Site

1218.18.54013 Boehringer Ingelheim Investigational Site

1218.18.54003 Boehringer Ingelheim Investigational Site

1218.18.54012 Boehringer Ingelheim Investigational Site

1218.18.54011 Boehringer Ingelheim Investigational Site

1218.18.54015 Boehringer Ingelheim Investigational Site

1218.18.54006 Boehringer Ingelheim Investigational Site

1218.18.54007 Boehringer Ingelheim Investigational Site

Patrocinadores