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Clinical Trial Details

Trial ID: L4721
Source ID: NCT00641043
Associated Drug: Placebo + Pioglitazone (30 Mg)
Title: Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00641043/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: placebo + pioglitazone (30 mg)|DRUG: Linagliptin + pioglitazone (30 mg)
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 baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetes 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 an 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
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 389
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-03
Completion Date:
Results First Posted: 2011-06-07
Last Update Posted: 2014-02-17
Locations: 1218.15.43004 Boehringer Ingelheim Investigational Site, Feldkirch, Austria|1218.15.43001 Boehringer Ingelheim Investigational Site, Graz, Austria|1218.15.43003 Boehringer Ingelheim Investigational Site, Wien, Austria|1218.15.43005 Boehringer Ingelheim Investigational Site, Wien, Austria|1218.15.30004 Boehringer Ingelheim Investigational Site, Athens, Greece|1218.15.30007 Boehringer Ingelheim Investigational Site, Athens, Greece|1218.15.30017 Boehringer Ingelheim Investigational Site, Ioannina, Greece|1218.15.30002 Boehringer Ingelheim Investigational Site, Melissia-Athens, Greece|1218.15.30003 Boehringer Ingelheim Investigational Site, Nikaia, Greece|1218.15.30006 Boehringer Ingelheim Investigational Site, Thessaloniki, Greece|1218.15.30014 Boehringer Ingelheim Investigational Site, Thessaloniki, Greece|1218.15.30016 Boehringer Ingelheim Investigational Site, Thessaloniki, Greece|1218.15.36003 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1218.15.36004 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1218.15.36006 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1218.15.36008 Boehringer Ingelheim Investigational Site, Debrecen, Hungary|1218.15.36005 Boehringer Ingelheim Investigational Site, Györ, Hungary|1218.15.36002 Boehringer Ingelheim Investigational Site, Szombathely, Hungary|1218.15.81001 Boehringer Ingelheim Investigational Site, Amagasaki, Hyogo, Japan|1218.15.81005 Boehringer Ingelheim Investigational Site, Koganei, Tokyo, Japan|1218.15.81002 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.15.81004 Boehringer Ingelheim Investigational Site, Shinjyuku-ku,Tokyo, Japan|1218.15.81003 Boehringer Ingelheim Investigational Site, Suita, Osaka,, Japan|1218.15.35007 Boehringer Ingelheim Investigational Site, Aveiro, Portugal|1218.15.35001 Boehringer Ingelheim Investigational Site, Lisboa, Portugal|1218.15.40504 Boehringer Ingelheim Investigational Site, Alba Iulia, Romania|1218.15.40501 Boehringer Ingelheim Investigational Site, Bucharest, Romania|1218.15.40502 Boehringer Ingelheim Investigational Site, Bucharest, Romania|1218.15.40503 Boehringer Ingelheim Investigational Site, Sibiu, Romania|1218.15.40505 Boehringer Ingelheim Investigational Site, Targu-Mures, Romania|1218.15.34002 Boehringer Ingelheim Investigational Site, Badalona, Spain|1218.15.34011 Boehringer Ingelheim Investigational Site, Badia del Vallés, Spain|1218.15.34001 Boehringer Ingelheim Investigational Site, Bercelona, Spain|1218.15.34012 Boehringer Ingelheim Investigational Site, Borges del Camp, Spain|1218.15.34013 Boehringer Ingelheim Investigational Site, Centelles, Spain|1218.15.34007 Boehringer Ingelheim Investigational Site, Granada, Spain|1218.15.34008 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), Spain|1218.15.34009 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), Spain|1218.15.34004 Boehringer Ingelheim Investigational Site, Madrid, Spain|1218.15.34006 Boehringer Ingelheim Investigational Site, Madrid, Spain|1218.15.34010 Boehringer Ingelheim Investigational Site, Sant Adrià del Besós (Barcelona), Spain|1218.15.34005 Boehringer Ingelheim Investigational Site, Sevilla, Spain|1218.15.34014 Boehringer Ingelheim Investigational Site, Vic (Barcelona), Spain
URL: https://clinicaltrials.gov/show/NCT00641043