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Clinical Trial Details

Trial ID: L6653
Source ID: NCT00798161
Associated Drug: Bi 1356
Title: Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00798161/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 1356|DRUG: BI 1356 + metformin|DRUG: Bi 1356 + metformin|DRUG: Metformin|DRUG: metformin|DRUG: matching placebo
Outcome Measures: Primary: HbA1c Change From Baseline at Week 24, HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and week 24 | Secondary: HbA1c Change From Baseline at Week 6, HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and week 6|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 baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and week 12|HbA1c Change From Baseline at Week 18, HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and week 18|FPG Change From Baseline at Week 24, This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication., Baseline and week 24|FPG Change From Baseline at Week 2, This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication., Baseline and week 2|FPG Change From Baseline at Week 6, This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication., Baseline and week 6|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|FPG Change From Baseline at Week 18, This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication., Baseline and week 18|Percentage of Patients With HbA1c <7.0% at Week 24, The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%., Baseline and Week 24|Percentage of Patients With HbA1c<7.0 at Week 24, The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%., Baseline and Week 24|Percentage of Patients With HbA1c <6.5% at Week 24, The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =\< 6.5%, Baseline and Week 24|Percentage of Patients With HbA1c < 6.5% at Week 24, The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%, Baseline and Week 24|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24, The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%., Baseline and week 24|Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24, This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication., Baseline and week 24|HbA1c Change From Baseline at Week 24 for Open-label Patients, HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted., Baseline and week 24|FPG Change From Baseline at Week 24 for Open-label Patients, This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted., Baseline and week 24|Use of Rescue Therapy, The use of rescue therapy (SUs, thiazolidinediones \[TZDs\], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast., 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 857
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-12
Completion Date:
Results First Posted: 2011-08-04
Last Update Posted: 2014-01-28
Locations: 1218.46.11005 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.46.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1218.46.11002 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada|1218.46.11006 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1218.46.11008 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1218.46.11004 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.46.11007 Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada|1218.46.11009 Boehringer Ingelheim Investigational Site, Oshawa, Ontario, Canada|1218.46.11010 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.46.38502 Boehringer Ingelheim Investigational Site, Karlovac, Croatia|1218.46.38503 Boehringer Ingelheim Investigational Site, Krapinske Toplice, Croatia|1218.46.38504 Boehringer Ingelheim Investigational Site, Osijek, Croatia|1218.46.38505 Boehringer Ingelheim Investigational Site, Rijeka, Croatia|1218.46.38501 Boehringer Ingelheim Investigational Site, Sisak, Croatia|1218.46.38506 Boehringer Ingelheim Investigational Site, Zagreb, Croatia|1218.46.37202 Boehringer Ingelheim Investigational Site, Pärnu, Estonia|1218.46.37201 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1218.46.37203 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1218.46.3303D Boehringer Ingelheim Investigational Site, Aire sur l'Aadour, France|1218.46.3308B Boehringer Ingelheim Investigational Site, Bischheim, France|1218.46.3305A Boehringer Ingelheim Investigational Site, Bourges, France|1218.46.3304F Boehringer Ingelheim Investigational Site, Bousse, France|1218.46.3306D Boehringer Ingelheim Investigational Site, Carresse Cassaber, France|1218.46.3308C Boehringer Ingelheim Investigational Site, Gambsheim, France|1218.46.3305D Boehringer Ingelheim Investigational Site, Garchizy, France|1218.46.3301A Boehringer Ingelheim Investigational Site, Grenoble cédex, France|1218.46.3305B Boehringer Ingelheim Investigational Site, Guerigny, France|1218.46.3304A Boehringer Ingelheim Investigational Site, Jarny, France|1218.46.3302D Boehringer Ingelheim Investigational Site, La Riche, France|1218.46.3307A Boehringer Ingelheim Investigational Site, La Seyne sur Mer, France|1218.46.3307E Boehringer Ingelheim Investigational Site, La Seyne sur Mer, France|1218.46.3305G Boehringer Ingelheim Investigational Site, Lury, France|1218.46.3304D Boehringer Ingelheim Investigational Site, Mars la Tour, France|1218.46.3304B Boehringer Ingelheim Investigational Site, Mondelange, France|1218.46.3303A Boehringer Ingelheim Investigational Site, Mont de Marsan, France|1218.46.3303C Boehringer Ingelheim Investigational Site, Mont de Marsan, France|1218.46.3303E Boehringer Ingelheim Investigational Site, Mont de Marsan, France|1218.46.3304C Boehringer Ingelheim Investigational Site, Moutiers, France|1218.46.3308F Boehringer Ingelheim Investigational Site, Mundolsheim, France|1218.46.3305C Boehringer Ingelheim Investigational Site, Nevers, France|1218.46.3305E Boehringer Ingelheim Investigational Site, Nevers, France|1218.46.3306A Boehringer Ingelheim Investigational Site, Ortez, France|1218.46.3306C Boehringer Ingelheim Investigational Site, Orthez, France|1218.46.3306E Boehringer Ingelheim Investigational Site, Orthez, France|1218.46.3306F Boehringer Ingelheim Investigational Site, Orthez, France|1218.46.3304E Boehringer Ingelheim Investigational Site, Pont à Mousson, France|1218.46.3302B Boehringer Ingelheim Investigational Site, Saint Avertin, France|1218.46.3302C Boehringer Ingelheim Investigational Site, Saint Avertin, France|1218.46.3306B Boehringer Ingelheim Investigational Site, Salies de Bearn, France|1218.46.3302E Boehringer Ingelheim Investigational Site, Savonnières, France|1218.46.3303B Boehringer Ingelheim Investigational Site, St Martin d'Oney, France|1218.46.3308A Boehringer Ingelheim Investigational Site, Strasbourg, France|1218.46.3308D Boehringer Ingelheim Investigational Site, Strasbourg, France|1218.46.3308E Boehringer Ingelheim Investigational Site, Strasbourg, France|1218.46.3307B Boehringer Ingelheim Investigational Site, Toulon, France|1218.46.3307C Boehringer Ingelheim Investigational Site, Toulon, France|1218.46.3307D Boehringer Ingelheim Investigational Site, Toulon, France|1218.46.3302A Boehringer Ingelheim Investigational Site, Tours, France|1218.46.3304H Boehringer Ingelheim Investigational Site, Vandoeuvre les Nancy, France|1218.46.49002 Boehringer Ingelheim Investigational Site, Bad Dürrheim-Sunthausen, Germany|1218.46.49001 Boehringer Ingelheim Investigational Site, Bad Mergentheim, Germany|1218.46.49006 Boehringer Ingelheim Investigational Site, Köln, Germany|1218.46.49003 Boehringer Ingelheim Investigational Site, München, Germany|1218.46.49008 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1218.46.49007 Boehringer Ingelheim Investigational Site, Schauenburg, Germany|1218.46.91009 Boehringer Ingelheim Investigational Site, Aurangabad, India|1218.46.91007 Boehringer Ingelheim Investigational Site, Babgalore, India|1218.46.91001 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.46.91004 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.46.91012 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.46.91011 Boehringer Ingelheim Investigational Site, Bhopal, India|1218.46.91003 Boehringer Ingelheim Investigational Site, Chennai, India|1218.46.91020 Boehringer Ingelheim Investigational Site, Chennai, India|1218.46.91018 Boehringer Ingelheim Investigational Site, Hyderadad, India|1218.46.91008 Boehringer Ingelheim Investigational Site, Jaipur, India|1218.46.91019 Boehringer Ingelheim Investigational Site, Madurai, India|1218.46.91013 Boehringer Ingelheim Investigational Site, Maharashtra, India|1218.46.91002 Boehringer Ingelheim Investigational Site, Manipal, India|1218.46.91015 Boehringer Ingelheim Investigational Site, Mumbai, India|1218.46.91014 Boehringer Ingelheim Investigational Site, Nagpur, India|1218.46.91017 Boehringer Ingelheim Investigational Site, New Delhi, India|1218.46.91016 Boehringer Ingelheim Investigational Site, P.O Trivandrum, India|1218.46.91010 Boehringer Ingelheim Investigational Site, Pune, India|1218.46.91006 Boehringer Ingelheim Investigational Site, West Bengal, India|1218.46.37001 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania|1218.46.37004 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania|1218.46.37003 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania|1218.46.52006 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico|1218.46.52002 Boehringer Ingelheim Investigational Site, Cuernavaca, Mexico|1218.46.52003 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1218.46.52004 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1218.46.52007 Boehringer Ingelheim Investigational Site, Mexico, Mexico|1218.46.52008 Boehringer Ingelheim Investigational Site, Mexico, Mexico|1218.46.52001 Boehringer Ingelheim Investigational Site, Pachuca, Mexico|1218.46.52010 Boehringer Ingelheim Investigational Site, Tijuana, Mexico|1218.46.52009 Boehringer Ingelheim Investigational Site, Veracruz, Mexico|1218.46.31004 Boehringer Ingelheim Investigational Site, 's Hertogenbosch, Netherlands|1218.46.31005 Boehringer Ingelheim Investigational Site, 's Hertogenbosch, Netherlands|1218.46.31001 Boehringer Ingelheim Investigational Site, Almere, Netherlands|1218.46.31002 Boehringer Ingelheim Investigational Site, Beek en Donk, Netherlands|1218.46.31008 Boehringer Ingelheim Investigational Site, Beek, Netherlands|1218.46.31010 Boehringer Ingelheim Investigational Site, Breda, Netherlands|1218.46.31011 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands|1218.46.31013 Boehringer Ingelheim Investigational Site, Groningen, Netherlands|1218.46.31012 Boehringer Ingelheim Investigational Site, Leiderdrop, Netherlands|1218.46.31016 Boehringer Ingelheim Investigational Site, Nijmegen, Netherlands|1218.46.31009 Boehringer Ingelheim Investigational Site, Rotterdam, Netherlands|1218.46.31014 Boehringer Ingelheim Investigational Site, Velp, Netherlands|1218.46.31015 Boehringer Ingelheim Investigational Site, Zoetermeer, Netherlands|1218.46.40001 Boehringer Ingelheim Investigational Site, Alba Iulia, Romania|1218.46.40005 Boehringer Ingelheim Investigational Site, Galati, Romania|1218.46.40003 Boehringer Ingelheim Investigational Site, Oradea, Romania|1218.46.40002 Boehringer Ingelheim Investigational Site, Ploiesti, Romania|1218.46.40004 Boehringer Ingelheim Investigational Site, Satu Mare, Romania|1218.46.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.46.70002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.46.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.46.70004 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.46.70006 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.46.70008 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.46.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.46.70007 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.46.46002 Boehringer Ingelheim Investigational Site, Goteborg, Sweden|1218.46.46004 Boehringer Ingelheim Investigational Site, Goteborg, Sweden|1218.46.46003 Boehringer Ingelheim Investigational Site, Malmo, Sweden|1218.46.46005 Boehringer Ingelheim Investigational Site, Stockholm, Sweden|1218.46.46001 Boehringer Ingelheim Investigational Site, Uppsala, Sweden|1218.46.2162A Boehringer Ingelheim Investigational Site, Bab Sâadoun Tunis, Tunisia|1218.46.2161A Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.46.2161B Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.46.2163A Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.46.2163B Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.46.38003 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.46.38001 Boehringer Ingelheim Investigational Site, Lviv, Ukraine|1218.46.38005 Boehringer Ingelheim Investigational Site, Lvov, Ukraine|1218.46.38004 Boehringer Ingelheim Investigational Site, Odesa, Ukraine|1218.46.38002 Boehringer Ingelheim Investigational Site, Odessa, Ukraine|1218.46.38006 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine
URL: https://clinicaltrials.gov/show/NCT00798161