Conditions: Diabetes Mellitus, Type 2
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2122
Healthy volunteers: no

Brief summary:
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)

Detailed description:

Arms:
arm 1: open label arm 2: open label

Interventions: intervention 1: linagliptine 5 mg intervention 2: linagliptine 5 mg and pioglitazone 30 mg
Intervention descriptions: intervention 1: safety and efficacy of linagliptine 5 mg open label intervention 2: efficacy and safety of the combination linagliptine and pioglitazone

Protocol document: