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Clinical Trial Details

Trial ID: L4648
Source ID: NCT00309608
Associated Drug: Linagliptin
Title: Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00309608/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Linagliptin|DRUG: Linagliptin|DRUG: Linagliptin|DRUG: Placebo|DRUG: Glimepiride
Outcome Measures: Primary: HbA1c Change From Baseline at Week 12, HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c., Baseline and week 12 | Secondary: Percentage of Patients With HbA1c<=7.0% at Week 12, Descriptive calculation of Patients with HbA1c \<= 7.0% at Week 12., week 12|Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12, This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication., Baseline and week 12
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 333
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2006-04
Completion Date:
Results First Posted: 2011-06-15
Last Update Posted: 2014-07-08
Locations: 1218.6.3304A Boehringer Ingelheim Investigational Site, Joue les Tours, France|1218.6.3305A Euraxi Pharma, Joue les Tours, France|1218.6.3302A Boehringer Ingelheim Investigational Site, Joué les Tours, France|1218.6.3303A Boehringer Ingelheim Investigational Site, Joué Les Tours, France|1218.6.3301A Boehringer Ingelheim Investigational Site, Paris cedex 13, France|1218.6.49007 Boehringer Ingelheim Investigational Site, Aschaffenburg, Germany|1218.6.49013 Boehringer Ingelheim Investigational Site, Bosenheim, Germany|1218.6.49008 Boehringer Ingelheim Investigational Site, Dresden, Germany|1218.6.49009 Boehringer Ingelheim Investigational Site, Düsseldorf, Germany|1218.6.49014 Boehringer Ingelheim Investigational Site, Heidelberg, Germany|1218.6.49012 Boehringer Ingelheim Investigational Site, Immenstadt, Germany|1218.6.49001 Boehringer Ingelheim Investigational Site, Mainz, Germany|1218.6.49005 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1218.6.49017 Boehringer Ingelheim Investigational Site, Offenbach a. M., Germany|1218.6.49002 Boehringer Ingelheim Investigational Site, Saarbrücken, Germany|1218.6.49011 Boehringer Ingelheim Investigational Site, Sinsheim, Germany|1218.6.49010 Boehringer Ingelheim Investigational Site, St. Ingbert/Oberwürzbach, Germany|1218.6.49015 Boehringer Ingelheim Investigational Site, Sulzbach-Rosenberg, Germany|1218.6.49016 Boehringer Ingelheim Investigational Site, Wangen, Germany|1218.6.49003 Boehringer Ingelheim Investigational Site, Würzburg, Germany|1218.6.42103 Boehringer Ingelheim Investigational Site, Banska Bystrica, Slovakia|1218.6.42104 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1218.6.42105 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1218.6.42101 Boehringer Ingelheim Investigational Site, Nove Mesto nad Vahom, Slovakia|1218.6.46003 Boehringer Ingelheim Investigational Site, Göteborg, Sweden|1218.6.46001 Boehringer Ingelheim Investigational Site, Malmö, Sweden|1218.6.46002 Boehringer Ingelheim Investigational Site, Uddevalla, Sweden|1218.6.46004 Boehringer Ingelheim Investigational Site, Uppsala, Sweden|1218.6.38002 Boehringer Ingelheim Investigational Site, Dnyepropetrovsk, Ukraine|1218.6.38001 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.6.38003 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.6.38005 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.6.44012 Boehringer Ingelheim Investigational Site, Ashford, United Kingdom|1218.6.44004 Boehringer Ingelheim Investigational Site, Baillieston, Glasgow, United Kingdom|1218.6.44002 Boehringer Ingelheim Investigational Site, Bath, United Kingdom|1218.6.44003 Boehringer Ingelheim Investigational Site, Birmingham, United Kingdom|1218.6.44013 Boehringer Ingelheim Investigational Site, Camberley, United Kingdom|1218.6.44016 Boehringer Ingelheim Investigational Site, Chorley, United Kingdom|1218.6.44007 Boehringer Ingelheim Investigational Site, Dundee, United Kingdom|1218.6.44006 Boehringer Ingelheim Investigational Site, Exeter, United Kingdom|1218.6.44005 Boehringer Ingelheim Investigational Site, Gillingham, United Kingdom|1218.6.44015 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom|1218.6.44008 Boehringer Ingelheim Investigational Site, Guildford, United Kingdom|1218.6.44017 Boehringer Ingelheim Investigational Site, Liverpool, United Kingdom|1218.6.44001 Boehringer Ingelheim Investigational Site, London, United Kingdom|1218.6.44018 Boehringer Ingelheim Investigational Site, Manchester, United Kingdom|1218.6.44009 Boehringer Ingelheim Investigational Site, Newcastle upon Tyne, United Kingdom|1218.6.44019 Boehringer Ingelheim Investigational Site, Reading, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00309608

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress