Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4476
Source ID: NCT01183013
Associated Drug: Pioglitazone 15 Mg
Title: 30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01183013/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Pioglitazone 15 mg|DRUG: Pioglitazone 45 mg|DRUG: Pioglitazone 30 mg|DRUG: Linagliptin 5mg / Pioglitazone 45 mg FDC|DRUG: Linagliptin 5mg / Pioglitazone 30 mg FDC|DRUG: Linagliptin 5mg|DRUG: Linagliptin 5mg / Pioglitazone 15 mg FDC
Outcome Measures: Primary: Change From Baseline in HbA1c After 30 Weeks of Treatment., HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c., Baseline and 30 weeks | Secondary: Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin., Baseline and 30 weeks|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin., Baseline and 30 weeks|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment), Glycosylated hemoglobin is reported as a percentage of the total hemoglobin., Baseline and 30 weeks|HbA1c Change From Baseline by Visit Over Time, HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment. by visit interaction., Baseline, week 6, week 12, week 18, week 24, week 30|Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment, The change from baseline is the FPG after 30 weeks minus the baseline FPG., Baseline and 30 weeks|Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time, The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction, Baseline, week 6, week 12, week 18, week 24, week 30|Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT), The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG., Baseline and 30 weeks|Time to First Use of Rescue Therapy, Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis., 30 weeks|Incidence of Rescue Therapy During the First 30 Weeks of Treatment, Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment., 30 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 936
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-08
Completion Date: 2013-02
Results First Posted: 2014-04-21
Last Update Posted: 2014-10-20
Locations: 1264.3.01026 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|1264.3.01021 Boehringer Ingelheim Investigational Site, Montgomery, Alabama, United States|1264.3.01020 Boehringer Ingelheim Investigational Site, Muscle Shoals, Alabama, United States|1264.3.01062 Boehringer Ingelheim Investigational Site, Chandler, Arizona, United States|1264.3.01064 Boehringer Ingelheim Investigational Site, Mesa, Arizona, United States|1264.3.01049 Boehringer Ingelheim Investigational Site, Carmichael, California, United States|1264.3.01078 Boehringer Ingelheim Investigational Site, Chino, California, United States|1264.3.01031 Boehringer Ingelheim Investigational Site, Concord, California, United States|1264.3.01037 Boehringer Ingelheim Investigational Site, Lakewood, California, United States|1264.3.01065 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1264.3.01006 Boehringer Ingelheim Investigational Site, Norwalk, California, United States|1264.3.01001 Boehringer Ingelheim Investigational Site, Rancho Cucamonga, California, United States|1264.3.01059 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1264.3.01023 Boehringer Ingelheim Investigational Site, Tarzana, California, United States|1264.3.01016 Boehringer Ingelheim Investigational Site, Tustin, California, United States|1264.3.01058 Boehringer Ingelheim Investigational Site, Valencia, California, United States|1264.3.01083 Boehringer Ingelheim Investigational Site, Westlake Village, California, United States|1264.3.01027 Boehringer Ingelheim Investigational Site, Denver, Colorado, United States|1264.3.01033 Boehringer Ingelheim Investigational Site, Norwalk, Connecticut, United States|1264.3.01035 Boehringer Ingelheim Investigational Site, Boca Raton, Florida, United States|1264.3.01015 Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States|1264.3.01082 Boehringer Ingelheim Investigational Site, Hialeah, Florida, United States|1264.3.01036 Boehringer Ingelheim Investigational Site, Jacksonville, Florida, United States|1264.3.01013 Boehringer Ingelheim Investigational Site, Longwood, Florida, United States|1264.3.01038 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1264.3.01042 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1264.3.01079 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1264.3.01019 Boehringer Ingelheim Investigational Site, Port Orange, Florida, United States|1264.3.01018 Boehringer Ingelheim Investigational Site, St. Cloud, Florida, United States|1264.3.01009 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States|1264.3.01012 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States|1264.3.01008 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States|1264.3.01055 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States|1264.3.01061 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States|1264.3.01074 Boehringer Ingelheim Investigational Site, Blue Ridge, Georgia, United States|1264.3.01084 Boehringer Ingelheim Investigational Site, Cartersville, Georgia, United States|1264.3.01060 Boehringer Ingelheim Investigational Site, Perry, Georgia, United States|1264.3.01050 Boehringer Ingelheim Investigational Site, Savannah, Georgia, United States|1264.3.01077 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1264.3.01052 Boehringer Ingelheim Investigational Site, Brownsburg, Indiana, United States|1264.3.01075 Boehringer Ingelheim Investigational Site, Evansville, Indiana, United States|1264.3.01076 Boehringer Ingelheim Investigational Site, Evansville, Indiana, United States|1264.3.01073 Boehringer Ingelheim Investigational Site, Franklin, Indiana, United States|1264.3.01002 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States|1264.3.01007 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States|1264.3.01010 Boehringer Ingelheim Investigational Site, Lexington, Kentucky, United States|1264.3.01028 Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, United States|1264.3.01029 Boehringer Ingelheim Investigational Site, Sunset, Louisiana, United States|1264.3.01069 Boehringer Ingelheim Investigational Site, Hyattsville, Maryland, United States|1264.3.01066 Boehringer Ingelheim Investigational Site, Southfield, Michigan, United States|1264.3.01057 Boehringer Ingelheim Investigational Site, Great Falls, Montana, United States|1264.3.01045 Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States|1264.3.01044 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States|1264.3.01022 Boehringer Ingelheim Investigational Site, Zanesville, Ohio, United States|1264.3.01032 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States|1264.3.01051 Boehringer Ingelheim Investigational Site, Fleetwood, Pennsylvania, United States|1264.3.01025 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States|1264.3.01081 Boehringer Ingelheim Investigational Site, Columbia, South Carolina, United States|1264.3.01003 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1264.3.01011 Boehringer Ingelheim Investigational Site, Kingsport, Tennessee, United States|1264.3.01017 Boehringer Ingelheim Investigational Site, Corpus Christi, Texas, United States|1264.3.01067 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1264.3.01004 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1264.3.01039 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1264.3.01041 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1264.3.01047 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1264.3.01070 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1264.3.01040 Boehringer Ingelheim Investigational Site, Killeen, Texas, United States|1264.3.01048 Boehringer Ingelheim Investigational Site, Midland, Texas, United States|1264.3.01030 Boehringer Ingelheim Investigational Site, New Braunfels, Texas, United States|1264.3.01071 Boehringer Ingelheim Investigational Site, North Richland Hills, Texas, United States|1264.3.01085 Boehringer Ingelheim Investigational Site, Plano, Texas, United States|1264.3.01046 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1264.3.01056 Boehringer Ingelheim Investigational Site, Norfolk, Virginia, United States|1264.3.37207 Boehringer Ingelheim Investigational Site, Harju, Estonia|1264.3.37209 Boehringer Ingelheim Investigational Site, Pärnu, Estonia|1264.3.37201 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1264.3.37202 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1264.3.37208 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1264.3.37203 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1264.3.37204 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1264.3.37205 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1264.3.37206 Boehringer Ingelheim Investigational Site, Tartu, Estonia|1264.3.37210 Boehringer Ingelheim Investigational Site, Viljandi County, Estonia|1264.3.49001 Boehringer Ingelheim Investigational Site, Bad Lauterberg / Harz, Germany|1264.3.49007 Boehringer Ingelheim Investigational Site, Dietzenbach, Germany|1264.3.49002 Boehringer Ingelheim Investigational Site, Dortmund, Germany|1264.3.49009 Boehringer Ingelheim Investigational Site, Essen, Germany|1264.3.49003 Boehringer Ingelheim Investigational Site, Hamburg, Germany|1264.3.49012 Boehringer Ingelheim Investigational Site, Ingelheim, Germany|1264.3.49008 Boehringer Ingelheim Investigational Site, Leipzig, Germany|1264.3.49005 Boehringer Ingelheim Investigational Site, Mainz, Germany|1264.3.49010 Boehringer Ingelheim Investigational Site, Offenbach, Germany|1264.3.49004 Boehringer Ingelheim Investigational Site, Stuhr, Germany|1264.3.37105 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia|1264.3.37112 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia|1264.3.37113 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia|1264.3.37110 Boehringer Ingelheim Investigational Site, Jelgava, Latvia|1264.3.37101 Boehringer Ingelheim Investigational Site, Liepaja, Latvia|1264.3.37106 Boehringer Ingelheim Investigational Site, Ogre, Latvia|1264.3.37104 Boehringer Ingelheim Investigational Site, Riga, Latvia|1264.3.37108 Boehringer Ingelheim Investigational Site, Riga, Latvia|1264.3.37109 Boehringer Ingelheim Investigational Site, Riga, Latvia|1264.3.37111 Boehringer Ingelheim Investigational Site, Riga, Latvia|1264.3.37107 Boehringer Ingelheim Investigational Site, Talsi, Latvia|1264.3.37102 Boehringer Ingelheim Investigational Site, Tukums, Latvia|1264.3.37103 Boehringer Ingelheim Investigational Site, Valmiera, Latvia|1264.3.34013 Boehringer Ingelheim Investigational Site, Badía del Vallès - Barcelona, Spain|1264.3.34001 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1264.3.34008 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1264.3.34005 Boehringer Ingelheim Investigational Site, Borges del Camp- Tarragona, Spain|1264.3.34006 Boehringer Ingelheim Investigational Site, Canet de Mar - Barcelona, Spain|1264.3.34010 Boehringer Ingelheim Investigational Site, Centelles - Barcelona, Spain|1264.3.34004 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat - Barcelona, Spain|1264.3.34009 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, Spain|1264.3.34002 Boehringer Ingelheim Investigational Site, Sant Adrià del Besós- Barcelona, Spain|1264.3.34007 Boehringer Ingelheim Investigational Site, Tarrega - Lleida, Spain|1264.3.34012 Boehringer Ingelheim Investigational Site, Valencia, Spain|1264.3.34011 Boehringer Ingelheim Investigational Site, Vic - Barcelona, Spain|1264.3.44032 Boehringer Ingelheim Investigational Site, Annan, United Kingdom|1264.3.44028 Boehringer Ingelheim Investigational Site, Ash Vale, Aldershot, United Kingdom|1264.3.44029 Boehringer Ingelheim Investigational Site, Baillieston, Glasgow, United Kingdom|1264.3.44008 Boehringer Ingelheim Investigational Site, Balham, United Kingdom|1264.3.44021 Boehringer Ingelheim Investigational Site, Bradford on Avon, United Kingdom|1264.3.44019 Boehringer Ingelheim Investigational Site, Burbage, United Kingdom|1264.3.44012 Boehringer Ingelheim Investigational Site, Chesterfield, United Kingdom|1264.3.44027 Boehringer Ingelheim Investigational Site, Chestfield, Whitstable, United Kingdom|1264.3.44011 Boehringer Ingelheim Investigational Site, Chippenham, United Kingdom|1264.3.44033 Boehringer Ingelheim Investigational Site, Johnstone, United Kingdom|1264.3.44007 Boehringer Ingelheim Investigational Site, Midsomer Norton, United Kingdom|1264.3.44034 Boehringer Ingelheim Investigational Site, Paisley, United Kingdom|1264.3.44031 Boehringer Ingelheim Investigational Site, Warminster, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01183013

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D336 Pioglitazone small molecule DB01132 Details