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Clinical Trial Details

Trial ID: L2921
Source ID: NCT00915772
Associated Drug: Linagliptin + Metformin
Title: Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00915772/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Linagliptin + metformin|DRUG: Linagliptin+metformin|DRUG: Metformin
Outcome Measures: Primary: Frequency of Patients With Adverse Events (AEs), This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures., 54 weeks|Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP), Baseline is defined as Visit 1 of 1218.52., 54 weeks|Change From Baseline at Week 54 in Pulse Rate, Baseline is defined as Visit 1 of 1218.52., 54 weeks|Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology, 54 weeks|Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry, ULN means upper limit of normal, 54 weeks|Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE, Frequency of patients with adverse events by treatment, primary system organ class and preferred term, Baseline and drug stop (up to 54 weeks) + 7 days | Secondary: Change in HbA1c From Baseline Over Time, HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52., 54 weeks|Number of Patients With HbA1c <7.0% After 54 Weeks, 54 weeks|Number of Patients With HbA1c <6.5% Over Time, 54 weeks|Number of Patients With HbA1c of at Least <0.5% Over Time, 54 weeks|Change in FPG From Baseline Over Time, Baseline is defined as visit 1 of 1218.52., 54 weeks|Number of Patients With Rescue Therapy, 54 weeks|Change in HbA1c From Baseline Over Time, HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772)., 78 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 567
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2009-06
Completion Date:
Results First Posted: 2012-07-18
Last Update Posted: 2014-05-14
Locations: 1218.52.11005 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.52.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1218.52.11002 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada|1218.52.11006 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1218.52.11008 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1218.52.11004 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.52.11007 Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada|1218.52.11010 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.52.38502 Boehringer Ingelheim Investigational Site, Karlovac, Croatia|1218.52.38503 Boehringer Ingelheim Investigational Site, Krapinske Toplice, Croatia|1218.52.38504 Boehringer Ingelheim Investigational Site, Osijek, Croatia|1218.52.38505 Boehringer Ingelheim Investigational Site, Rijeka, Croatia|1218.52.38501 Boehringer Ingelheim Investigational Site, Sisak, Croatia|1218.52.37202 Boehringer Ingelheim Investigational Site, Pärnu, Estonia|1218.52.37201 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1218.52.37203 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1218.52.3303D Boehringer Ingelheim Investigational Site, Aire sur l'Aadour, France|1218.52.3308B Boehringer Ingelheim Investigational Site, Bischheim, France|1218.52.3305A Boehringer Ingelheim Investigational Site, Bourges, France|1218.52.3304F Boehringer Ingelheim Investigational Site, Bousse, France|1218.52.3308C Boehringer Ingelheim Investigational Site, Gambsheim, France|1218.52.3301A Boehringer Ingelheim Investigational Site, Grenoble cédex, France|1218.52.3305B Boehringer Ingelheim Investigational Site, Guerigny, France|1218.52.3304A Boehringer Ingelheim Investigational Site, Jarny, France|1218.52.3302D Boehringer Ingelheim Investigational Site, La Riche, France|1218.52.9999 Boehringer Ingelheim Investigational Site, La Riche, France|1218.52.3307A Boehringer Ingelheim Investigational Site, La Seyne sur Mer, France|1218.52.3307E Boehringer Ingelheim Investigational Site, La Seyne sur Mer, France|1218.52.3305G Boehringer Ingelheim Investigational Site, Lury, France|1218.52.3303A Boehringer Ingelheim Investigational Site, Mont de Marsan, France|1218.52.3308F Boehringer Ingelheim Investigational Site, Mundolsheim, France|1218.52.3305E Boehringer Ingelheim Investigational Site, Nevers, France|1218.52.3306A Boehringer Ingelheim Investigational Site, Ortez, France|1218.52.3306C Boehringer Ingelheim Investigational Site, Orthez, France|1218.52.3302E Boehringer Ingelheim Investigational Site, Savonnières, France|1218.52.3303B Boehringer Ingelheim Investigational Site, St Martin d'Oney, France|1218.52.3308A Boehringer Ingelheim Investigational Site, Strasbourg, France|1218.52.3308D Boehringer Ingelheim Investigational Site, Strasbourg, France|1218.52.3308E Boehringer Ingelheim Investigational Site, Strasbourg, France|1218.52.3307D Boehringer Ingelheim Investigational Site, Toulon, France|1218.52.3302A Boehringer Ingelheim Investigational Site, Tours, France|1218.52.49002 Boehringer Ingelheim Investigational Site, Bad Dürrheim-Sunthausen, Germany|1218.52.49006 Boehringer Ingelheim Investigational Site, Köln, Germany|1218.52.49003 Boehringer Ingelheim Investigational Site, München, Germany|1218.52.49007 Boehringer Ingelheim Investigational Site, Schauenburg, Germany|1218.52.91009 Boehringer Ingelheim Investigational Site, Aurangabad, India|1218.52.91001 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.52.91004 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.52.91012 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.52.91011 Boehringer Ingelheim Investigational Site, Bhopal, India|1218.52.91003 Boehringer Ingelheim Investigational Site, Chennai, India|1218.52.91020 Boehringer Ingelheim Investigational Site, Chennai, India|1218.52.91018 Boehringer Ingelheim Investigational Site, Hyderadad, India|1218.52.91008 Boehringer Ingelheim Investigational Site, Jaipur, India|1218.52.91002 Boehringer Ingelheim Investigational Site, Karnataka, India|1218.52.91007 Boehringer Ingelheim Investigational Site, Karnataka, India|1218.52.91019 Boehringer Ingelheim Investigational Site, Madurai, India|1218.52.91013 Boehringer Ingelheim Investigational Site, Maharashtra, India|1218.52.91015 Boehringer Ingelheim Investigational Site, Mumbai, India|1218.52.91014 Boehringer Ingelheim Investigational Site, Nagpru, India|1218.52.91016 Boehringer Ingelheim Investigational Site, P.O.Trivandrum, India|1218.52.91010 Boehringer Ingelheim Investigational Site, Pune, India|1218.52.91006 Boehringer Ingelheim Investigational Site, West Bengal, India|1218.52.37001 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania|1218.52.37004 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania|1218.52.37003 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania|1218.52.52006 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico|1218.52.52002 Boehringer Ingelheim Investigational Site, Cuernavaca, Mexico|1218.52.52004 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1218.52.52007 Boehringer Ingelheim Investigational Site, Mexico, Mexico|1218.52.52008 Boehringer Ingelheim Investigational Site, Mexico, Mexico|1218.52.52010 Boehringer Ingelheim Investigational Site, Tijuana, Mexico|1218.52.52009 Boehringer Ingelheim Investigational Site, Veracruz, Mexico|1218.52.31004 Boehringer Ingelheim Investigational Site, 's Hertogenbosch, Netherlands|1218.52.31005 Boehringer Ingelheim Investigational Site, 's Hertogenbosch, Netherlands|1218.52.31001 Boehringer Ingelheim Investigational Site, Almere, Netherlands|1218.52.31002 Boehringer Ingelheim Investigational Site, Beek en Donk, Netherlands|1218.52.31010 Boehringer Ingelheim Investigational Site, Breda, Netherlands|1218.52.31013 Boehringer Ingelheim Investigational Site, Groningen, Netherlands|1218.52.31014 Boehringer Ingelheim Investigational Site, Velp, Netherlands|1218.52.31015 Boehringer Ingelheim Investigational Site, Zoetermeer, Netherlands|1218.52.40001 Boehringer Ingelheim Investigational Site, Alba Iulia, Romania|1218.52.40005 Boehringer Ingelheim Investigational Site, Galati, Romania|1218.52.40003 Boehringer Ingelheim Investigational Site, Oradea, Romania|1218.52.40002 Boehringer Ingelheim Investigational Site, Ploiesti, Romania|1218.52.40004 Boehringer Ingelheim Investigational Site, Satu Mare, Romania|1218.52.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.52.70002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.52.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.52.70004 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.52.70006 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.52.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.52.70007 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.52.46002 Boehringer Ingelheim Investigational Site, Goteborg, Sweden|1218.52.46003 Boehringer Ingelheim Investigational Site, Malmo, Sweden|1218.52.46005 Boehringer Ingelheim Investigational Site, Stockholm, Sweden|1218.52.46001 Boehringer Ingelheim Investigational Site, Uppsala, Sweden|1218.52.2162A Boehringer Ingelheim Investigational Site, Bab Saâdoun Tunis, Tunisia|1218.52.2162B Boehringer Ingelheim Investigational Site, Bab Sâadoun Tunis, Tunisia|1218.52.9992 Boehringer Ingelheim Investigational Site, Bab Sâadoun Tunis, Tunisia|1218.52.2161A Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.52.2161B Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.52.2163A Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.52.2163B Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.52.9991 Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.52.9993 Boehringer Ingelheim Investigational Site, Tunis, Tunisia|1218.52.38003 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.52.38001 Boehringer Ingelheim Investigational Site, Lviv, Ukraine|1218.52.38005 Boehringer Ingelheim Investigational Site, Lvov, Ukraine|1218.52.38002 Boehringer Ingelheim Investigational Site, Odessa, Ukraine|1218.52.38004 Boehringer Ingelheim Investigational Site, Odessa, Ukraine|1218.52.38006 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine
URL: https://clinicaltrials.gov/show/NCT00915772

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details