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Clinical Trial Details

Trial ID: L5581
Source ID: NCT01012037
Associated Drug: Linagliptin Low Dose
Title: Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01012037/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: linagliptin low dose|DRUG: placebo|DRUG: linagliptin medium dose
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 baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin., Baseline and week 12 | Secondary: HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis, Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction., Baseline and week 6|HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis, Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction., Baseline and week 12|FPG Change From Baseline at Week 12, Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin., Baseline and week 12|FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis, Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction., Baseline and week 6|FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis, Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction., Baseline and week 12|Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12, Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF., Week 12|Percentage of Patients With Rescue Therapy, Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC., 12 weeks|The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment, Percentage of those patients with baseline HbA1c \>= 7.0% who had HbA1c \< 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF., 12 weeks|The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment, Percentage of those patients with baseline HbA1c \>= 6.5% who had HbA1c \< 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF., 12 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 491
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date:
Results First Posted: 2011-10-31
Last Update Posted: 2014-06-27
Locations: 1218.62.32003 Boehringer Ingelheim Investigational Site, De Pinte, Belgium|1218.62.32008 Boehringer Ingelheim Investigational Site, Kortenaken, Belgium|1218.62.32009 Boehringer Ingelheim Investigational Site, Kumtich, Belgium|1218.62.32005 Boehringer Ingelheim Investigational Site, Massemen-Wetteren, Belgium|1218.62.32004 Boehringer Ingelheim Investigational Site, Natoye, Belgium|1218.62.32007 Boehringer Ingelheim Investigational Site, Sint-Job-in't-Goor, Belgium|1218.62.32002 Boehringer Ingelheim Investigational Site, Tessenderlo, Belgium|1218.62.32006 Boehringer Ingelheim Investigational Site, Wilsele, Belgium|1218.62.11012 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.62.11007 Boehringer Ingelheim Investigational Site, Burnaby, British Columbia, Canada|1218.62.11011 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada|1218.62.11006 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada|1218.62.11001 Boehringer Ingelheim Investigational Site, Barrie, Ontario, Canada|1218.62.11003 Boehringer Ingelheim Investigational Site, Brampton, Ontario, Canada|1218.62.11004 Boehringer Ingelheim Investigational Site, Markham, Ontario, Canada|1218.62.11005 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1218.62.11008 Boehringer Ingelheim Investigational Site, Smiths Falls, Ontario, Canada|1218.62.11013 Boehringer Ingelheim Investigational Site, Strathroy, Ontario, Canada|1218.62.11014 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.62.11010 Boehringer Ingelheim Investigational Site, Charlottetown, Prince Edward Island, Canada|1218.62.11002 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada|1218.62.11009 Boehringer Ingelheim Investigational Site, Point Claire, Quebec, Canada|1218.62.3303C Boehringer Ingelheim Investigational Site, Bort les Orgues, France|1218.62.3306A Boehringer Ingelheim Investigational Site, Bourg des cptes, France|1218.62.3303D Boehringer Ingelheim Investigational Site, Bugeat, France|1218.62.3302H Boehringer Ingelheim Investigational Site, Corsept, France|1218.62.3308A Boehringer Ingelheim Investigational Site, Derval, France|1218.62.3302B Boehringer Ingelheim Investigational Site, La Chapelle sur Erdre, France|1218.62.3304A Boehringer Ingelheim Investigational Site, Levallois Perret, France|1218.62.3305A Boehringer Ingelheim Investigational Site, Marseille, France|1218.62.3305B Boehringer Ingelheim Investigational Site, Marseille, France|1218.62.3305G Boehringer Ingelheim Investigational Site, Marseille, France|1218.62.3305H Boehringer Ingelheim Investigational Site, Marseille, France|1218.62.3301A Boehringer Ingelheim Investigational Site, Nantes Cedex 1, France|1218.62.3302A Boehringer Ingelheim Investigational Site, Nantes, France|1218.62.3304B Boehringer Ingelheim Investigational Site, Paris, France|1218.62.3304D Boehringer Ingelheim Investigational Site, Paris, France|1218.62.3305F Boehringer Ingelheim Investigational Site, Roquevaire, France|1218.62.3305I Boehringer Ingelheim Investigational Site, Roquevaire, France|1218.62.3303A Boehringer Ingelheim Investigational Site, Rosiers d'Egletons, France|1218.62.3303H Boehringer Ingelheim Investigational Site, Sainte Fortunade, France|1218.62.3302I Boehringer Ingelheim Investigational Site, Sautron, France|1218.62.3302G Boehringer Ingelheim Investigational Site, VUE, France|1218.62.91001 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.62.91004 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.62.91003 Boehringer Ingelheim Investigational Site, Hyderabad, Andra Pradesh, India|1218.62.91005 Boehringer Ingelheim Investigational Site, Nagpru, India|1218.62.91002 Boehringer Ingelheim Investigational Site, Trivandrum, India|1218.62.39010 Boehringer Ingelheim Investigational Site, Ancona, Italy|1218.62.39006 Boehringer Ingelheim Investigational Site, Catania, Italy|1218.62.39004 Boehringer Ingelheim Investigational Site, Genova, Italy|1218.62.39009 Boehringer Ingelheim Investigational Site, Gissi (CH), Italy|1218.62.39003 Boehringer Ingelheim Investigational Site, Palermo, Italy|1218.62.39001 Boehringer Ingelheim Investigational Site, Pisa, Italy|1218.62.39002 Boehringer Ingelheim Investigational Site, Pordenone, Italy|1218.62.39012 Boehringer Ingelheim Investigational Site, Ravenna, Italy|1218.62.39007 Boehringer Ingelheim Investigational Site, Roma, Italy|1218.62.39011 Boehringer Ingelheim Investigational Site, Roma, Italy|1218.62.82005 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1218.62.82006 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1218.62.82003 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of|1218.62.82004 Boehringer Ingelheim Investigational Site, Pucheon, Korea, Republic of|1218.62.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.62.82001 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of|1218.62.60001 Boehringer Ingelheim Investigational Site, Kelantan Kota Bahru, Malaysia|1218.62.60005 Boehringer Ingelheim Investigational Site, Kuala Lumpur, Malaysia|1218.62.60002 Boehringer Ingelheim Investigational Site, Penang, Malaysia|1218.62.60003 Boehringer Ingelheim Investigational Site, Putrajaya, Malaysia|1218.62.60004 Boehringer Ingelheim Investigational Site, Seremban, Malaysia|1218.62.31007 Boehringer Ingelheim Investigational Site, Almere, Netherlands|1218.62.31004 Boehringer Ingelheim Investigational Site, Breezerveld, Netherlands|1218.62.31005 Boehringer Ingelheim Investigational Site, Etten-Leur, Netherlands|1218.62.31002 Boehringer Ingelheim Investigational Site, Lieshout, Netherlands|1218.62.31001 Boehringer Ingelheim Investigational Site, Oude Pekela, Netherlands|1218.62.31008 Boehringer Ingelheim Investigational Site, Voerendaal, Netherlands|1218.62.31009 Boehringer Ingelheim Investigational Site, Wildervank, Netherlands|1218.62.31003 Boehringer Ingelheim Investigational Site, Woerden, Netherlands|1218.62.34003 Boehringer Ingelheim Investigational Site, Badia del Vallés (Barcelona), Spain|1218.62.34002 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), Spain|1218.62.34005 Boehringer Ingelheim Investigational Site, Madrid, Spain|1218.62.34006 Boehringer Ingelheim Investigational Site, Madrid, Spain|1218.62.34007 Boehringer Ingelheim Investigational Site, Madrid, Spain|1218.62.34001 Boehringer Ingelheim Investigational Site, Palma (Mallorca), Spain|1218.62.34008 Boehringer Ingelheim Investigational Site, Palma de Mallorca, Spain
URL: https://clinicaltrials.gov/show/NCT01012037

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress