Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5918
Source ID: NCT00819091
Associated Drug: Bi 1356
Title: Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00819091/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 1356|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18, HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline, week 18 | Secondary: Change From Baseline in Fasting Plasma Glucose at Week 18, Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication., Baseline, week 18|Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18, An absolute efficacy response is defined as HbA1c \< 7.0% at 18 weeks. A non-response is defined as HbA1c \>= 7.0% at 18 weeks., week 18|Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18, An absolute efficacy response is defined as HbA1c \< 6.5% at 18 weeks. A non-response is defined as HbA1c \>= 6.5% at 18 weeks., week 18|Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18, An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks., Baseline, week 18|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6, HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline, week 6|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12, HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline, week 12|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18, HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline, week 18|Change From Baseline in Fasting Plasma Glucose at Week 6, Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication., Baseline, week 6|Change From Baseline in Fasting Plasma Glucose at Week 12, Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication., Baseline, week 12
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 245
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-12
Completion Date:
Results First Posted: 2011-08-01
Last Update Posted: 2014-06-27
Locations: 1218.35.10002 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|1218.35.10001 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1218.35.10016 Boehringer Ingelheim Investigational Site, National City, California, United States|1218.35.10017 Boehringer Ingelheim Investigational Site, Ft. Lauderdale, Florida, United States|1218.35.10021 Boehringer Ingelheim Investigational Site, Ft. Lauderdale, Florida, United States|1218.35.10013 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.35.10015 Boehringer Ingelheim Investigational Site, Flint, Michigan, United States|1218.35.10018 Boehringer Ingelheim Investigational Site, Asheville, North Carolina, United States|1218.35.10004 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1218.35.10005 Boehringer Ingelheim Investigational Site, Portland, Oregon, United States|1218.35.10020 Boehringer Ingelheim Investigational Site, Greenville, South Carolina, United States|1218.35.10009 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.35.10019 Boehringer Ingelheim Investigational Site, Sugar Land, Texas, United States|1218.35.54003 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.35.54005 Boehringer Ingelheim Investigational Site, Corrientes, Argentina|1218.35.54001 Boehringer Ingelheim Investigational Site, Mar del Plata, Argentina|1218.35.54006 Boehringer Ingelheim Investigational Site, Parque Velez Sarfield, Argentina|1218.35.36001 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1218.35.36002 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1218.35.36004 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1218.35.36005 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1218.35.36003 Boehringer Ingelheim Investigational Site, Debrecen, Hungary|1218.35.91003 Boehringer Ingelheim Investigational Site, Aligarh, Uttar Pradesh, India|1218.35.91007 Boehringer Ingelheim Investigational Site, Aminjikarai, Tamilnadu, India|1218.35.91001 Boehringer Ingelheim Investigational Site, Bangalore, Karnataka, India|1218.35.91004 Boehringer Ingelheim Investigational Site, Bangalore, Karnataka, India|1218.35.91002 Boehringer Ingelheim Investigational Site, Indore, India|1218.35.91008 Boehringer Ingelheim Investigational Site, Mumbai, Maharastra, India|1218.35.91005 Boehringer Ingelheim Investigational Site, Nagpur, Maharashtra, India|1218.35.91006 Boehringer Ingelheim Investigational Site, Pune, Maharastra, India|1218.35.81003 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.35.81001 Boehringer Ingelheim Investigational Site, Shinjyuku-ku,Tokyo, Japan|1218.35.81002 Boehringer Ingelheim Investigational Site, Suita, Osaka,, Japan|1218.35.48002 Boehringer Ingelheim Investigational Site, Bialystok, Poland|1218.35.48004 Boehringer Ingelheim Investigational Site, Lublin, Poland|1218.35.48003 Boehringer Ingelheim Investigational Site, Poznan, Poland|1218.35.48001 Boehringer Ingelheim Investigational Site, Rzeszow, Poland|1218.35.48005 Boehringer Ingelheim Investigational Site, Wroclaw, Poland|1218.35.70008 Boehringer Ingelheim Investigational Site, Arkhangelsk, Russian Federation|1218.35.70001 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.35.70002 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.35.70003 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.35.70006 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.35.70009 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.35.70007 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation
URL: https://clinicaltrials.gov/show/NCT00819091

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress