Status:
COMPLETED
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-82 years
Phase:
PHASE3
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 d...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signed and dated written informed consent in accordance with the GCP and local legislation.
- Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.
- 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:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2122 Patients enrolled
Trial Details
Trial ID
NCT00736099
Start Date
August 1 2008
Last Update
June 27 2014
Active Locations (232)
Enter a location and click search to find clinical trials sorted by distance.
1
1218.40.10003 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
2
1218.40.10014 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States
3
1218.40.10001 Boehringer Ingelheim Investigational Site
Walnut Creek, California, United States
4
1218.40.10021 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States