A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Key facts

Study ID

NCT00740051

Run by

Boehringer Ingelheim

People needed

227

Starts

2008-08-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 1218.50.10011 Boehringer Ingelheim Investigational Site — Peoria, Arizona, United States
• 1218.50.10013 Boehringer Ingelheim Investigational Site — Greenbrae, California, United States
• 1218.50.10016 Boehringer Ingelheim Investigational Site — Harbor City, California, United States
• 1218.50.10017 Boehringer Ingelheim Investigational Site — Huntington Park, California, United States
• 1218.50.10006 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1218.50.10007 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1218.50.10004 Boehringer Ingelheim Investigational Site — Statesville, North Carolina, United States
• 1218.50.10002 Boehringer Ingelheim Investigational Site — Eugene, Oregon, United States
• 1218.50.10015 Boehringer Ingelheim Investigational Site — Greer, South Carolina, United States
• 1218.50.10005 Boehringer Ingelheim Investigational Site — Kingsport, Tennessee, United States
• 1218.50.10012 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1218.50.10022 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1218.50.10010 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1218.50.10018 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1218.50.11001 Boehringer Ingelheim Investigational Site — Edmonton, Alberta, Canada
• 1218.50.11003 Boehringer Ingelheim Investigational Site — Edmonton, Alberta, Canada
• 1218.50.11005 Boehringer Ingelheim Investigational Site — Sarnia, Ontario, Canada
• 1218.50.11002 Boehringer Ingelheim Investigational Site — Montague, Prince Edward Island, Canada
• 1218.50.11004 Boehringer Ingelheim Investigational Site — Saskatoon, Saskatchewan, Canada
• 1218.50.52007 Boehringer Ingelheim Investigational Site — Aguascalientes, Mexico
• 1218.50.52010 Boehringer Ingelheim Investigational Site — Guadalajara, Mexico
• 1218.50.52009 Boehringer Ingelheim Investigational Site — León, Mexico
• 1218.50.52002 Boehringer Ingelheim Investigational Site — México, Mexico
• 1218.50.52004 Boehringer Ingelheim Investigational Site — México, Mexico
• 1218.50.10009 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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