Ensayo abierto de 78 semanas de duración, de extensión de otros estudios, para evaluar la seguridad y eficacia de BI 1356 (5 mg) en monoterapia o en combinación con otros fármacos antidiabéticos en pacientes con diabetes tipo 2.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.

Boehringer Ingelheim España, S.A.0 个研究点目标入组 1,900 人开始时间: 2008年7月14日最近更新: 2021年10月8日

适应症

试验速览

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•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

•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.

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