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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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Linagliptin (Drug); Linagliptin Placebo (Drug); Glimepiride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Summary

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)

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

HbA1c Change From Baseline at Week 18 (Interim Analysis)

HbA1c Change From Baseline at Week 18 (Final Analysis)

Secondary outcome:

Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)

Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)

Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)

Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)

The Change in HbA1c From Baseline by Visit Over Time

The Change in FPG From Baseline by Visit Over Time

Eligibility

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

Locations and Contacts

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, Mexico, Mexico

1218.50.52008 Boehringer Ingelheim Investigational Site, Mexico, Mexico

1218.50.52001 Boehringer Ingelheim Investigational Site, Monterrey, Mexico

1218.50.52003 Boehringer Ingelheim Investigational Site, Monterrey, Mexico

1218.50.52004 Boehringer Ingelheim Investigational Site, México, Mexico

1218.50.52005 Boehringer Ingelheim Investigational Site, México, Mexico

1218.50.63003 Boehringer Ingelheim Investigational Site, Cebu, Philippines

1218.50.63005 Boehringer Ingelheim Investigational Site, Cebu, Philippines

1218.50.63006 Boehringer Ingelheim Investigational Site, Manila, Philippines

1218.50.63008 Boehringer Ingelheim Investigational Site, Manila, Philippines

1218.50.63001 Boehringer Ingelheim Investigational Site, Marikina, Philippines

1218.50.63004 Boehringer Ingelheim Investigational Site, Marikina, Philippines

1218.50.63007 Boehringer Ingelheim Investigational Site, Pasay, Philippines

1218.50.63002 Boehringer Ingelheim Investigational Site, Pasig, Philippines

1218.50.63009 Boehringer Ingelheim Investigational Site, Pasig, Philippines

1218.50.40004 Boehringer Ingelheim Investigational Site, Brasov, Romania

1218.50.40001 Boehringer Ingelheim Investigational Site, Bucharest, Romania

1218.50.40002 Boehringer Ingelheim Investigational Site, Bucharest, Romania

1218.50.40005 Boehringer Ingelheim Investigational Site, Galati, Romania

1218.50.40003 Boehringer Ingelheim Investigational Site, Sibiu, Romania

1218.50.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

1218.50.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

1218.50.70002 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1218.50.70004 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1218.50.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1218.50.38002 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine

1218.50.38001 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1218.50.38004 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1218.50.38003 Boehringer Ingelheim Investigational Site, Lvov, Ukraine

1218.50.38005 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine

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

1218.50.11001 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

1218.50.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

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

1218.50.11005 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada

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

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

1218.50.11004 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada

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

Additional Information

Starting date: August 2008
Last updated: June 17, 2014

Page last updated: August 23, 2015

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