Patients with type 2 Diabetes Mellitus.
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Linagliptin
Current Sponsor code: BI 1356
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent, at the latest by the date of Visit 1, in accordance with the GCP and local legislation. 2. Patients completing the entire treatment period as a double-blind (DB) trial whether or not they have been treated with rescue medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 that 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of BI 1356 (5mg/ once daily) given for 78 weeks in different modalities of treatment.;Secondary Objective: ;Primary end point(s): There is no primary endpoint in a statistical sense in this study. Instead, safety and tolerability will be assessed in a descriptive analysis based on: • Incidence and intensity of AEs (e.g. oedema rate, weight gain). • Withdrawal due to AEs. • Clinically relevant new or worsening findings in physical examination as reported as adverse event. • Changes from baseline in vital signs (blood pressure and pulse rate). • Clinically relevant new or worsening findings in 12-lead ECG as reported as adverse event. • Changes from baseline in clinical laboratory assessments. | — |
Countries
Austria, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed