Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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)

Key facts

Study ID

NCT00736099

Run by

Boehringer Ingelheim

People needed

2122

Starts

2008-08-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older, up to 82. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 1218.40.10014 Boehringer Ingelheim Investigational Site — Spring Valley, California, United States
• 1218.40.10001 Boehringer Ingelheim Investigational Site — Walnut Creek, California, United States
• 1218.40.10021 Boehringer Ingelheim Investigational Site — Northglenn, Colorado, United States
• 1218.40.10010 Boehringer Ingelheim Investigational Site — Hollywood, Florida, United States
• 1218.40.10011 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1218.40.10016 Boehringer Ingelheim Investigational Site — Eugene, Oregon, United States
• 1218.40.10002 Boehringer Ingelheim Investigational Site — Greer, South Carolina, United States
• 1218.40.10004 Boehringer Ingelheim Investigational Site — Simpsonville, South Carolina, United States
• 1218.40.10005 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1218.40.10018 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1218.40.10007 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1218.40.10009 Boehringer Ingelheim Investigational Site — Federal Way, Washington, United States
• 1218.40.54002 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1218.40.54010 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1218.40.54011 Boehringer Ingelheim Investigational Site — Mendoza, Argentina
• 1218.40.54015 Boehringer Ingelheim Investigational Site — Parque Velez Sarfield, Argentina
• 1218.40.43001 Boehringer Ingelheim Investigational Site — Graz, Austria
• 1218.40.43005 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1218.40.32005 Boehringer Ingelheim Investigational Site — Bruges, Belgium
• 1218.40.32007 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 1218.40.32006 Boehringer Ingelheim Investigational Site — Edegem, Belgium
• 1218.40.32004 Boehringer Ingelheim Investigational Site — Genk, Belgium
• 1218.40.32003 Boehringer Ingelheim Investigational Site — Ghent, Belgium
• 1218.40.32002 Boehringer Ingelheim Investigational Site — Huy, Belgium
• 1218.40.10003 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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