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

PHASE3CompletedINTERVENTIONAL
Enrollment

227

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

August 31, 2010

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Linagliptin

5mg once daily

DRUG

Linagliptin Placebo

0 mg placebo comparator for part 1 of study (to 18 weeks)

DRUG

Glimepiride

1-4mg for part 2 of study (weeks 19-52)

Trial Locations (53)

Unknown

1218.50.10009 Boehringer Ingelheim Investigational Site, Birmingham

1218.50.10011 Boehringer Ingelheim Investigational Site, Peoria

1218.50.10013 Boehringer Ingelheim Investigational Site, Greenbrae

1218.50.10016 Boehringer Ingelheim Investigational Site, Harbor City

1218.50.10017 Boehringer Ingelheim Investigational Site, Huntington Park

1218.50.10006 Boehringer Ingelheim Investigational Site, Los Angeles

1218.50.10007 Boehringer Ingelheim Investigational Site, Miami

1218.50.10004 Boehringer Ingelheim Investigational Site, Statesville

1218.50.10002 Boehringer Ingelheim Investigational Site, Eugene

1218.50.10015 Boehringer Ingelheim Investigational Site, Greer

1218.50.10005 Boehringer Ingelheim Investigational Site, Kingsport

1218.50.10012 Boehringer Ingelheim Investigational Site, Dallas

1218.50.10022 Boehringer Ingelheim Investigational Site, Dallas

1218.50.10010 Boehringer Ingelheim Investigational Site, San Antonio

1218.50.10018 Boehringer Ingelheim Investigational Site, San Antonio

1218.50.11001 Boehringer Ingelheim Investigational Site, Edmonton

1218.50.11003 Boehringer Ingelheim Investigational Site, Edmonton

1218.50.11005 Boehringer Ingelheim Investigational Site, Sarnia

1218.50.11002 Boehringer Ingelheim Investigational Site, Montague

1218.50.11004 Boehringer Ingelheim Investigational Site, Saskatoon

1218.50.52007 Boehringer Ingelheim Investigational Site, Aguascalientes

1218.50.52010 Boehringer Ingelheim Investigational Site, Guadalajara

1218.50.52009 Boehringer Ingelheim Investigational Site, León

1218.50.52002 Boehringer Ingelheim Investigational Site, México

1218.50.52004 Boehringer Ingelheim Investigational Site, México

1218.50.52005 Boehringer Ingelheim Investigational Site, México

1218.50.52008 Boehringer Ingelheim Investigational Site, México

1218.50.52001 Boehringer Ingelheim Investigational Site, Monterrey

1218.50.52003 Boehringer Ingelheim Investigational Site, Monterrey

1218.50.63003 Boehringer Ingelheim Investigational Site, Cebu

1218.50.63005 Boehringer Ingelheim Investigational Site, Cebu

1218.50.63006 Boehringer Ingelheim Investigational Site, Manila

1218.50.63008 Boehringer Ingelheim Investigational Site, Manila

1218.50.63001 Boehringer Ingelheim Investigational Site, Marikina City

1218.50.63004 Boehringer Ingelheim Investigational Site, Marikina City

1218.50.63007 Boehringer Ingelheim Investigational Site, Pasay

1218.50.63002 Boehringer Ingelheim Investigational Site, Pasig

1218.50.63009 Boehringer Ingelheim Investigational Site, Pasig

1218.50.40004 Boehringer Ingelheim Investigational Site, Brasov

1218.50.40001 Boehringer Ingelheim Investigational Site, Bucharest

1218.50.40002 Boehringer Ingelheim Investigational Site, Bucharest

1218.50.40005 Boehringer Ingelheim Investigational Site, Galati

1218.50.40003 Boehringer Ingelheim Investigational Site, Sibiu

1218.50.70001 Boehringer Ingelheim Investigational Site, Moscow

1218.50.70003 Boehringer Ingelheim Investigational Site, Moscow

1218.50.70002 Boehringer Ingelheim Investigational Site, Saint Petersburg

1218.50.70004 Boehringer Ingelheim Investigational Site, Saint Petersburg

1218.50.70005 Boehringer Ingelheim Investigational Site, Saint Petersburg

1218.50.38002 Boehringer Ingelheim Investigational Site, Kharkiv

1218.50.38001 Boehringer Ingelheim Investigational Site, Kiev

1218.50.38004 Boehringer Ingelheim Investigational Site, Kiev

1218.50.38003 Boehringer Ingelheim Investigational Site, Lviv

1218.50.38005 Boehringer Ingelheim Investigational Site, Vinnitsa

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY