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Clinical Trial Details

Trial ID: L2865
Source ID: NCT00602472
Associated Drug: Linagliptin
Title: BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00602472/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: linagliptin|DRUG: placebo
Outcome Measures: Primary: HbA1c Change From Baseline to 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 to 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 to 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 to 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 to 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 to 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 to 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 to Week 18, This change from baseline reflects the Week 18 FPG minus the Week 0 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%. Only patients with baseline HbA1c \>= 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 Who Have a HbA1c Lowering by 0.5% at Week 24, The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline 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
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1058
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-02
Completion Date:
Results First Posted: 2011-06-15
Last Update Posted: 2014-03-28
Locations: 1218.18.54001 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.18.54002 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.18.54004 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.18.54005 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.18.54010 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.18.54014 Boehringer Ingelheim Investigational Site, Corrientes, Argentina|1218.18.54009 Boehringer Ingelheim Investigational Site, Córdoba, Argentina|1218.18.54013 Boehringer Ingelheim Investigational Site, Córdoba, Argentina|1218.18.54003 Boehringer Ingelheim Investigational Site, Mar del Plata, Argentina|1218.18.54012 Boehringer Ingelheim Investigational Site, Mar del Plata, Argentina|1218.18.54011 Boehringer Ingelheim Investigational Site, Mendoza, Argentina|1218.18.54015 Boehringer Ingelheim Investigational Site, Parque Velez Sarfield, Argentina|1218.18.54006 Boehringer Ingelheim Investigational Site, Rosario, Argentina|1218.18.54007 Boehringer Ingelheim Investigational Site, Salta, Argentina|1218.18.32005 Boehringer Ingelheim Investigational Site, Brugge, Belgium|1218.18.32007 Boehringer Ingelheim Investigational Site, Brussel, Belgium|1218.18.32006 Boehringer Ingelheim Investigational Site, Edegem, Belgium|1218.18.32004 Boehringer Ingelheim Investigational Site, Genk, Belgium|1218.18.32003 Boehringer Ingelheim Investigational Site, Gent, Belgium|1218.18.32002 Boehringer Ingelheim Investigational Site, Huy, Belgium|1218.18.32001 Boehringer Ingelheim Investigational Site, Liège, Belgium|1218.18.01005 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.18.01010 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.18.01003 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1218.18.01011 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1218.18.01006 Boehringer Ingelheim Investigational Site, Etobicoke, Ontario, Canada|1218.18.01009 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.18.01002 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1218.18.01012 Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada|1218.18.01008 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1218.18.01001 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.18.01004 Boehringer Ingelheim Investigational Site, Montague, Prince Edward Island, Canada|1218.18.01007 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada|1218.18.86001 Boehringer Ingelheim Investigational Site, Beijing, China|1218.18.86002 Boehringer Ingelheim Investigational Site, Beijing, China|1218.18.86004 Boehringer Ingelheim Investigational Site, Beijing, China|1218.18.86013 Boehringer Ingelheim Investigational Site, Chengdu, Sichuan Province, China|1218.18.86009 Boehringer Ingelheim Investigational Site, Dalian, China|1218.18.86011 Boehringer Ingelheim Investigational Site, Guangzhou, China|1218.18.86014 Boehringer Ingelheim Investigational Site, Haerbin, China|1218.18.86005 Boehringer Ingelheim Investigational Site, Nanjing, Jiangsu Province, China|1218.18.86008 Boehringer Ingelheim Investigational Site, Qingdao, China|1218.18.86015 Boehringer Ingelheim Investigational Site, Shanghai, China|1218.18.86010 Boehringer Ingelheim Investigational Site, Shen Yang, China|1218.18.86003 Boehringer Ingelheim Investigational Site, Weizikeng, China|1218.18.86012 Boehringer Ingelheim Investigational Site, Wuhan, Hubei Province, China|1218.18.86007 Boehringer Ingelheim Investigational Site, Wuhan, China|1218.18.86006 Boehringer Ingelheim Investigational Site, Xian, Shanxi Province, China|1218.18.49004 Boehringer Ingelheim Investigational Site, Aschaffenburg, Germany|1218.18.49028 Boehringer Ingelheim Investigational Site, Bad Mergentheim, Germany|1218.18.49022 Boehringer Ingelheim Investigational Site, Berlin, Germany|1218.18.49024 Boehringer Ingelheim Investigational Site, Bosenheim, Germany|1218.18.49020 Boehringer Ingelheim Investigational Site, Dresden, Germany|1218.18.49101 Boehringer Ingelheim Investigational Site, Mainz, Germany|1218.18.49003 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1218.18.49007 Boehringer Ingelheim Investigational Site, Nürnberg, Germany|1218.18.49014 Boehringer Ingelheim Investigational Site, Saarbrücken, Germany|1218.18.82004 Boehringer Ingelheim Investigational Site, Busan, Korea, Republic of|1218.18.82011 Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of|1218.18.82008 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of|1218.18.82010 Boehringer Ingelheim Investigational Site, Jeonju, Korea, Republic of|1218.18.82002 Boehringer Ingelheim Investigational Site, Pusan, Korea, Republic of|1218.18.82001 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.18.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.18.82006 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.18.82007 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.18.82009 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.18.82003 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of|1218.18.63005 Boehringer Ingelheim Investigational Site, Manila, Philippines|1218.18.63002 Boehringer Ingelheim Investigational Site, Marikina, Philippines|1218.18.63001 Boehringer Ingelheim Investigational Site, Pasig, Philippines|1218.18.63004 Boehringer Ingelheim Investigational Site, Quezon City, Philippines|1218.18.63003 Boehringer Ingelheim Investigational Site, San Juan, Philippines|1218.18.70014 Boehringer Ingelheim Investigational Site, Arkhangelsk, Russian Federation|1218.18.70012 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.18.70013 Boehringer Ingelheim Investigational Site, Rostov-on-Don, Russian Federation|1218.18.70016 Boehringer Ingelheim Investigational Site, Samara, Russian Federation|1218.18.70015 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.18.88605 Boehringer Ingelheim Investigational Site, Changhua, Taiwan|1218.18.88604 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1218.18.88606 Boehringer Ingelheim Investigational Site, Tainan, Taiwan|1218.18.88601 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1218.18.88602 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1218.18.88603 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1218.18.88607 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1218.18.88608 Boehringer Ingelheim Investigational Site, Taoyuan, Taiwan|1218.18.90003 Boehringer Ingelheim Investigational Site, Erzurum, Turkey|1218.18.90005 Boehringer Ingelheim Investigational Site, Istanbul, Turkey|1218.18.90001 Boehringer Ingelheim Investigational Site, Izmir, Turkey|1218.18.90004 Boehringer Ingelheim Investigational Site, Konya, Turkey|1218.18.44005 Boehringer Ingelheim Investigational Site, Ashford, United Kingdom|1218.18.44004 Boehringer Ingelheim Investigational Site, Baillieston, Glasgow, United Kingdom|1218.18.44001 Boehringer Ingelheim Investigational Site, Bath, United Kingdom|1218.18.44003 Boehringer Ingelheim Investigational Site, Burbage, United Kingdom|1218.18.44010 Boehringer Ingelheim Investigational Site, Bury St Edmonds, United Kingdom|1218.18.44009 Boehringer Ingelheim Investigational Site, Cardiff, United Kingdom|1218.18.44008 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom|1218.18.44002 Boehringer Ingelheim Investigational Site, Penarth, United Kingdom|1218.18.44006 Boehringer Ingelheim Investigational Site, Reading, United Kingdom|1218.18.44007 Boehringer Ingelheim Investigational Site, Waterloo, Liverpool, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00602472

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress