A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.
The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)
Inclusion criteria:
Exclusion criteria:
Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who:
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.
Capital Federal, Argentina
Capital Federal, Argentina
Parque Velez Sarfield, Argentina
Haerbin, China
Andhra Pradesh, India
Kerala, India
Maharashtra, India
Uttar Pradesh, India
Amagasaki, Hyogo, Japan
Koganei, Tokyo, Japan
Osaka, Osaka, Japan
Suita, Osaka,, Japan
Kelantan, Malaysia
Col.Americana, Guadalajara, Jalisco, Mexico
Faccionamiento Lomas de Campestre,AGUASCAL, Mexico
Monterrey N.L., Mexico
Greenhills, San Juan, Philippines
Badia Del Vallés, Spain
Borges Del Camp, Spain
Sant Adrià Del Besós (Barcelona), Spain
Baillieston, Glasgow, United Kingdom
Bury Saint Edmonds, United Kingdom
Waterloo, Liverpool, United Kingdom