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Clinical Trial Details

Trial ID: L7328
Source ID: NCT00740051
Associated Drug: Linagliptin
Title: 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
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00740051/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Linagliptin|DRUG: Linagliptin Placebo|DRUG: Glimepiride
Outcome Measures: Primary: HbA1c Change From Baseline at Week 18 (Interim Analysis), HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance., Baseline and week 18|HbA1c Change From Baseline at Week 18 (Final Analysis), HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report., Baseline and week 18 | Secondary: Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis), This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis)., Baseline and week 18|Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis), Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance., Week 18|Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis), Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance., Week 18|Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis), Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance., Week 18|The Change in HbA1c From Baseline by Visit Over Time, HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent., Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52|The Change in FPG From Baseline by Visit Over Time, This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG., Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 227
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date:
Results First Posted: 2011-10-26
Last Update Posted: 2014-06-27
Locations: 1218.50.10009 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|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, 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
URL: https://clinicaltrials.gov/show/NCT00740051

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress