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Clinical Trial Details

Trial ID: L5097
Source ID: NCT00749190
Associated Drug: Bi 10773
Title: BI 10773 add-on to Metformin in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00749190/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 10773|DRUG: placebo|DRUG: sitagliptin
Outcome Measures: Primary: Change From Baseline in HbA1c After 12 Weeks of Treatment, Change from baseline in HbA1c after 12 weeks of treatment. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group., Baseline and 12 weeks | Secondary: Change of FPG From Baseline After 12 Weeks of Treatment, Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group., Baseline and 12 weeks|Change of HbA1c From Baseline Over Time, Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis., Baseline and weeks 4, 8 and 12|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment, Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression, Baseline and 12 weeks|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment, Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression, Baseline and 12 weeks|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI), Results for change of FPI from baseline at week 12 based on ANCOVA, Baseline and 12 weeks|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR), HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA., Baseline and 12 weeks|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B), HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA., Baseline and 12 weeks|Change of Body Weight After 12 Weeks of Treatment, Results for change of body weight after 12 weeks of treatment based on ANCOVA., Baseline and 12 weeks|Trough Concentrations of Empagliflozin in Plasma, (Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing., Days 28, 56 and 84
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 495
Study Type: INTERVENTIONAL
Study Designs: Allocation: |Intervention Model: PARALLEL|Masking: |Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date:
Results First Posted: 2014-06-13
Last Update Posted: 2014-06-13
Locations: 1245.10.10026 Boehringer Ingelheim Investigational Site, Chula Vista, California, United States|1245.10.10001 Boehringer Ingelheim Investigational Site, Mission Viejo, California, United States|1245.10.10011 Boehringer Ingelheim Investigational Site, Pasadena, California, United States|1245.10.10028 Boehringer Ingelheim Investigational Site, Spring Valley, California, United States|1245.10.10027 Boehringer Ingelheim Investigational Site, Walnut Creek, California, United States|1245.10.10004 Boehringer Ingelheim Investigational Site, Clearwarter, Florida, United States|1245.10.10021 Boehringer Ingelheim Investigational Site, Melbourne, Florida, United States|1245.10.10005 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1245.10.10019 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1245.10.10024 Boehringer Ingelheim Investigational Site, St. Cloud, Florida, United States|1245.10.10014 Boehringer Ingelheim Investigational Site, Roswell, Georgia, United States|1245.10.10016 Boehringer Ingelheim Investigational Site, Staten Island, New York, United States|1245.10.10009 Boehringer Ingelheim Investigational Site, Shelby, North Carolina, United States|1245.10.10006 Boehringer Ingelheim Investigational Site, Wadsworth, Ohio, United States|1245.10.10023 Boehringer Ingelheim Investigational Site, Norristown, Pennsylvania, United States|1245.10.10010 Boehringer Ingelheim Investigational Site, Clemson, South Carolina, United States|1245.10.10015 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1245.10.10012 Boehringer Ingelheim Investigational Site, Temple, Texas, United States|1245.10.10025 Boehringer Ingelheim Investigational Site, Federal Way, Washington, United States|1245.10.54002 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.10.54004 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.10.54008 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.10.54006 Boehringer Ingelheim Investigational Site, Mar del Plata, Argentina|1245.10.54005 Boehringer Ingelheim Investigational Site, Mendoza, Argentina|1245.10.43002 Boehringer Ingelheim Investigational Site, Graz, Austria|1245.10.43004 Boehringer Ingelheim Investigational Site, Innsbruck, Austria|1245.10.43001 Boehringer Ingelheim Investigational Site, Wien, Austria|1245.10.43003 Boehringer Ingelheim Investigational Site, Wien, Austria|1245.10.42001 Boehringer Ingelheim Investigational Site, Breclav, Czech Republic|1245.10.42003 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1245.10.42005 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1245.10.42002 Boehringer Ingelheim Investigational Site, Hodonin, Czech Republic|1245.10.37201 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1245.10.37202 Boehringer Ingelheim Investigational Site, Tartu, Estonia|1245.10.58006 Boehringer Ingelheim Investigational Site, Kerava, Finland|1245.10.58003 Boehringer Ingelheim Investigational Site, Oulu, Finland|1245.10.58004 Boehringer Ingelheim Investigational Site, Tampere, Finland|1245.10.58001 Boehringer Ingelheim Investigational Site, Turku, Finland|1245.10.3302A Boehringer Ingelheim Investigational Site, Bondy Cedex, France|1245.10.3302B Boehringer Ingelheim Investigational Site, Bondy Cedex, France|1245.10.3310A Boehringer Ingelheim Investigational Site, Caen Cedex 5, France|1245.10.3310B Boehringer Ingelheim Investigational Site, Caen Cedex 5, France|1245.10.3310C Boehringer Ingelheim Investigational Site, Caen Cedex 5, France|1245.10.3301A Boehringer Ingelheim Investigational Site, Corbeil Essonnes, France|1245.10.3301B Boehringer Ingelheim Investigational Site, Corbeil Essonnes, France|1245.10.3303A Boehringer Ingelheim Investigational Site, La Rochelle Cedex 1, France|1245.10.3303B Boehringer Ingelheim Investigational Site, La Rochelle Cedex 1, France|1245.10.3303C Boehringer Ingelheim Investigational Site, La Rochelle Cedex 1, France|1245.10.3303D Boehringer Ingelheim Investigational Site, La Rochelle Cedex 1, France|1245.10.3308A Boehringer Ingelheim Investigational Site, Le Grau du Roi, France|1245.10.3308B Boehringer Ingelheim Investigational Site, Le Grau du Roi, France|1245.10.3309A Boehringer Ingelheim Investigational Site, Nanterre Cedex, France|1245.10.3306A Boehringer Ingelheim Investigational Site, Narbonne Cedex, France|1245.10.3306B Boehringer Ingelheim Investigational Site, Narbonne Cedex, France|1245.10.3307A Boehringer Ingelheim Investigational Site, Quimper, France|1245.10.3304A Boehringer Ingelheim Investigational Site, Reims Cedex, France|1245.10.3304B Boehringer Ingelheim Investigational Site, Reims Cedex, France|1245.10.3304C Boehringer Ingelheim Investigational Site, Reims Cedex, France|1245.10.3311A Boehringer Ingelheim Investigational Site, Saint Mandé, France|1245.10.3311B Boehringer Ingelheim Investigational Site, Saint Mandé, France|1245.10.3311C Boehringer Ingelheim Investigational Site, Saint Mandé, France|1245.10.3311D Boehringer Ingelheim Investigational Site, Saint Mandé, France|1245.10.3305A Boehringer Ingelheim Investigational Site, Valenciennes, France|1245.10.3305B Boehringer Ingelheim Investigational Site, Valenciennes, France|1245.10.3305C Boehringer Ingelheim Investigational Site, Valenciennes, France|1245.10.3305D Boehringer Ingelheim Investigational Site, Valenciennes, France|1245.10.49001 Boehringer Ingelheim Investigational Site, Erlangen, Germany|1245.10.49003 Boehringer Ingelheim Investigational Site, Frankfurt, Germany|1245.10.49002 Boehringer Ingelheim Investigational Site, Hamburg, Germany|1245.10.49004 Boehringer Ingelheim Investigational Site, Rehlingen-Siersburg, Germany|1245.10.36001 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1245.10.36003 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1245.10.36004 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1245.10.36005 Boehringer Ingelheim Investigational Site, Gyor, Hungary|1245.10.36002 Boehringer Ingelheim Investigational Site, Szombathely, Hungary|1245.10.37101 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia|1245.10.37105 Boehringer Ingelheim Investigational Site, Kuldiga, Latvia|1245.10.37106 Boehringer Ingelheim Investigational Site, Ogre, Latvia|1245.10.37103 Boehringer Ingelheim Investigational Site, Riga, Latvia|1245.10.37107 Boehringer Ingelheim Investigational Site, Riga, Latvia|1245.10.37102 Boehringer Ingelheim Investigational Site, Talsi, Latvia|1245.10.37104 Boehringer Ingelheim Investigational Site, Valmiera, Latvia|1245.10.47003 Boehringer Ingelheim Investigational Site, Hamar, Norway|1245.10.47005 Boehringer Ingelheim Investigational Site, Oslo, Norway|1245.10.47001 Boehringer Ingelheim Investigational Site, Stavanger, Norway|1245.10.47004 Boehringer Ingelheim Investigational Site, Ålesund, Norway|1245.10.40001 Boehringer Ingelheim Investigational Site, Alba Iulia, Romania|1245.10.40005 Boehringer Ingelheim Investigational Site, Baia Mare Maramures, Romania|1245.10.40003 Boehringer Ingelheim Investigational Site, Brasov, Romania|1245.10.40002 Boehringer Ingelheim Investigational Site, Bucharest, Romania|1245.10.40007 Boehringer Ingelheim Investigational Site, Bucharest, Romania|1245.10.40004 Boehringer Ingelheim Investigational Site, Galati, Romania|1245.10.40006 Boehringer Ingelheim Investigational Site, Satu Mare, Romania|1245.10.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.10.70002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.10.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.10.70007 Boehringer Ingelheim Investigational Site, Saratov, Russian Federation|1245.10.70004 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.10.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.10.70006 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.10.62003 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1245.10.62001 Boehringer Ingelheim Investigational Site, Nitra, Slovakia|1245.10.62002 Boehringer Ingelheim Investigational Site, Nitra, Slovakia|1245.10.62004 Boehringer Ingelheim Investigational Site, Presov, Slovakia|1245.10.34002 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1245.10.34001 Boehringer Ingelheim Investigational Site, Girona, Spain|1245.10.34010 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), Spain|1245.10.34004 Boehringer Ingelheim Investigational Site, Málaga, Spain|1245.10.34005 Boehringer Ingelheim Investigational Site, Palma (Mallorca), Spain|1245.10.34006 Boehringer Ingelheim Investigational Site, Palma de Mallorca, Spain|1245.10.34008 Boehringer Ingelheim Investigational Site, Santander, Spain|1245.10.38002 Boehringer Ingelheim Investigational Site, Dnepropetrovsk, Ukraine|1245.10.38005 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine|1245.10.38004 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1245.10.38003 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1245.10.38001 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine
URL: https://clinicaltrials.gov/show/NCT00749190

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress