Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: linagliptine 5 mg; linagliptine 5 mg and pioglitazone 30 mg
Intervention description: safety and efficacy of linagliptine 5 mg open label; efficacy and safety of the combination linagliptine and pioglitazone
Intervention MeSH terms: Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2122.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: No

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)
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed and dated written informed consent in accordance with the GCP and local
             legislation.

          2. Patients completing the entire treatment period as a double blind trial whether or not
             they have been treated with rescue medication.

        Exclusion criteria:

          1. Patients who meet one or more of the withdrawal criteria of the treatment period of
             the previous trial.

          2. Pre-menopausal women (last menstruation =< 1 year prior to signing 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 transdermal patch, intra
                  uterine devices/systems (IUDs/IUSs), oral, implantable or injectable
                  contraceptives, true sexual abstinence (when this is in line with the preferred
                  and usual lifestyle of the patient; periodic abstinence [e.g. calendar,
                  ovulation, symptothermal, post-ovulation methods] and withdrawal are not
                  acceptable methods of birth control) and vasectomised partners. No exception will
                  be made.

          3. Alcohol abuse within the 3 months prior to informed consent that would interfere with
             trial participation.

          4. Drug abuse which, in the opinion of the investigator, would interfere with trial
             participation.

          5. 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.