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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: BI 1356 (Drug); Glimepiride (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Ext: Option 4, Email: clintriage.rdg@boehringer-ingelheim.com

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)

Official title: A Randomised, db, Placebo-Controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-Blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)

Study design: Treatment, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint in this study is the change from baseline in HbA1c after 18 weeks of treatment.

Secondary outcome: Key secondary endpoint is safety in this patient population with longer term (34 week) treatment in comparison to a sulfonylurea drug (glimepiride)

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion Criteria:

- Myocardial infarction, stroke or Transient ischaemic attack in last 6 months

- Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity

drugs in past 3 months

- Impaired hepatic function

- Severe renal impairment

- current treatment with systemic steroids

- change in dosage of thyroid hormones

- hereditary galactose intolerance

Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Ext: Option 4, Email: clintriage.rdg@boehringer-ingelheim.com

1218.50.52001 Boehringer Ingelheim Investigational Site, Monterrey, Mexico; Not yet recruiting

1218.50.52002 Boehringer Ingelheim Investigational Site, Mexico, Mexico; Not yet recruiting

1218.50.52003 Boehringer Ingelheim Investigational Site, Monterrey, Mexico; Not yet recruiting

1218.50.52004 Boehringer Ingelheim Investigational Site, México, Mexico; Not yet recruiting

1218.50.52005 Boehringer Ingelheim Investigational Site, México, Mexico; Not yet recruiting

1218.50.52006 Boehringer Ingelheim Investigational Site, Aguasclaintes, Mexico; Not yet recruiting

1218.50.52007 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico; Not yet recruiting

1218.50.52009 Boehringer Ingelheim Investigational Site, León, Mexico; Not yet recruiting

1218.50.52010 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico; Not yet recruiting

1218.50.52008 Boehringer Ingelheim Investigational Site, MEXICO, Mexico; Not yet recruiting

1218.50.63001 Boehringer Ingelheim Investigational Site, Marikina, Philippines; Recruiting

1218.50.63002 Boehringer Ingelheim Investigational Site, Pasig, Philippines; Recruiting

1218.50.63003 Boehringer Ingelheim Investigational Site, Cebu, Philippines; Recruiting

1218.50.63004 Boehringer Ingelheim Investigational Site, Marikina, Philippines; Recruiting

1218.50.63005 Boehringer Ingelheim Investigational Site, Cebu, Philippines; Recruiting

1218.50.63006 Boehringer Ingelheim Investigational Site, Manila, Philippines; Recruiting

1218.50.63007 Boehringer Ingelheim Investigational Site, Pasay, Philippines; Recruiting

1218.50.63008 Boehringer Ingelheim Investigational Site, Manila, Philippines; Recruiting

1218.50.63009 Boehringer Ingelheim Investigational Site, Pasig, Philippines; Recruiting

1218.50.40001 Boehringer Ingelheim Investigational Site, Bucharest, Romania; Not yet recruiting

1218.50.40002 Boehringer Ingelheim Investigational Site, Bucharest, Romania; Recruiting

1218.50.40003 Boehringer Ingelheim Investigational Site, Sibiu, Romania; Not yet recruiting

1218.50.40005 Boehringer Ingelheim Investigational Site, Galati, Romania; Not yet recruiting

1218.50.40004 Boehringer Ingelheim Investigational Site, Brasov, Romania; Recruiting

1218.50.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Not yet recruiting

1218.50.70002 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Not yet recruiting

1218.50.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Not yet recruiting

1218.50.70004 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Not yet recruiting

1218.50.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Not yet recruiting

1218.50.38001 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Not yet recruiting

1218.50.38002 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine; Not yet recruiting

1218.50.38003 Boehringer Ingelheim Investigational Site, Lvov, Ukraine; Not yet recruiting

1218.50.38004 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Not yet recruiting

1218.50.38005 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine; Not yet recruiting

1218.50.10009 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States; Recruiting

1218.50.11001 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada; Recruiting

1218.50.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada; Recruiting

1218.50.10011 Boehringer Ingelheim Investigational Site, Peoria, Arizona, United States; Recruiting

1218.50.10006 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States; Recruiting

1218.50.10013 Boehringer Ingelheim Investigational Site, Greenbrae, California, United States; Recruiting

1218.50.10016 Boehringer Ingelheim Investigational Site, Harbor City, California, United States; Recruiting

1218.50.10017 Boehringer Ingelheim Investigational Site, Huntington Park, California, United States; Terminated

1218.50.10007 Boehringer Ingelheim Investigational Site, Miami, Florida, United States; Recruiting

1218.50.10003 Boehringer Ingelheim Investigational Site, Paducah, Kentucky, United States; Recruiting

1218.50.10004 Boehringer Ingelheim Investigational Site, Statesville, North Carolina, United States; Terminated

1218.50.11005 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada; Recruiting

1218.50.10002 Boehringer Ingelheim Investigational Site, Eugene, Oregon, United States; Recruiting

1218.50.11002 Boehringer Ingelheim Investigational Site, Montague, Prince Edward Island, Canada; Recruiting

1218.50.11004 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada; Recruiting

1218.50.10015 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States; Recruiting

1218.50.10005 Boehringer Ingelheim Investigational Site, Kingsport, Tennessee, United States; Recruiting

1218.50.10010 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States; Recruiting

1218.50.10012 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States; Recruiting

1218.50.10018 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States; Recruiting

1218.50.10022 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States; Recruiting

Starting date: August 2008
Last updated: January 26, 2009