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Clinical Trial Details

Trial ID: L6020
Source ID: NCT00601250
Associated Drug: Linagliptin
Title: Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00601250/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: linagliptin|DRUG: linagliptin
Outcome Measures: Primary: HbA1c Change From Baseline at 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 at 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 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. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and week 12|HbA1c Change From Baseline at 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 at 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 at 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 at 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 at 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-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 7.0% 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 \>= 7.0%. 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 7.0% 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 \>= 7.0%., 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 \>= 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 \>= 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 from baseline \>= 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|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24, This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication., Baseline and week 24|2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24, This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication., Baseline and week 24
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 701
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-01
Completion Date:
Results First Posted: 2011-06-07
Last Update Posted: 2014-01-28
Locations: 1218.17.10003 Boehringer Ingelheim Investigational Site, Chula Vista, California, United States|1218.17.10014 Boehringer Ingelheim Investigational Site, Spring Valley, California, United States|1218.17.10001 Boehringer Ingelheim Investigational Site, Walnut Creek, California, United States|1218.17.10021 Boehringer Ingelheim Investigational Site, Northglenn, Colorado, United States|1218.17.10010 Boehringer Ingelheim Investigational Site, Hollywood, Florida, United States|1218.17.10011 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.17.10008 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States|1218.17.10017 Boehringer Ingelheim Investigational Site, Gurnee, Illinois, United States|1218.17.10006 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States|1218.17.10012 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States|1218.17.10013 Boehringer Ingelheim Investigational Site, Mentor, Ohio, United States|1218.17.10015 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States|1218.17.10016 Boehringer Ingelheim Investigational Site, Eugene, Oregon, United States|1218.17.10002 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1218.17.10004 Boehringer Ingelheim Investigational Site, Simpsonville, South Carolina, United States|1218.17.10005 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.17.10018 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.17.10007 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1218.17.10009 Boehringer Ingelheim Investigational Site, Federal Way, Washington, United States|1218.17.42006 Boehringer Ingelheim Investigational Site, Breclav, Czech Republic|1218.17.42001 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1218.17.42004 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1218.17.42007 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1218.17.42009 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1218.17.42008 Boehringer Ingelheim Investigational Site, Hodonin, Czech Republic|1218.17.42003 Boehringer Ingelheim Investigational Site, Olomouc, Czech Republic|1218.17.35806 Boehringer Ingelheim Investigational Site, Helsinki, Finland|1218.17.35804 Boehringer Ingelheim Investigational Site, Jyväskylä, Finland|1218.17.35801 Boehringer Ingelheim Investigational Site, Kuopio, Finland|1218.17.35803 Boehringer Ingelheim Investigational Site, Oulu, Finland|1218.17.35805 Boehringer Ingelheim Investigational Site, Seinäjoki, Finland|1218.17.35802 Boehringer Ingelheim Investigational Site, Turku, Finland|1218.17.30004 Boehringer Ingelheim Investigational Site, Athens, Greece|1218.17.30013 Boehringer Ingelheim Investigational Site, Athens, Greece|1218.17.30011 Boehringer Ingelheim Investigational Site, Piraeus, Greece|1218.17.91009 Boehringer Ingelheim Investigational Site, Andhra Pradesh, India|1218.17.91002 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.17.91005 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.17.91012 Boehringer Ingelheim Investigational Site, Chennai, India|1218.17.91014 Boehringer Ingelheim Investigational Site, Chennai, India|1218.17.91010 Boehringer Ingelheim Investigational Site, Hyderabad, India|1218.17.91006 Boehringer Ingelheim Investigational Site, Jaipur, India|1218.17.91007 Boehringer Ingelheim Investigational Site, Karnataka, India|1218.17.91008 Boehringer Ingelheim Investigational Site, Mangalore, India|1218.17.91004 Boehringer Ingelheim Investigational Site, Mumbai, India|1218.17.91011 Boehringer Ingelheim Investigational Site, Nagpur, India|1218.17.91003 Boehringer Ingelheim Investigational Site, Nasik, India|1218.17.91001 Boehringer Ingelheim Investigational Site, Trivandrum, India|1218.17.91013 Boehringer Ingelheim Investigational Site, Uttar Pradesh, India|1218.17.97274 Boehringer Ingelheim Investigational Site, Afula, Israel|1218.17.97273 Boehringer Ingelheim Investigational Site, Haifa, Israel|1218.17.97275 Boehringer Ingelheim Investigational Site, Holon, Israel|1218.17.97271 Boehringer Ingelheim Investigational Site, Jerusalem, Israel|1218.17.97272 Boehringer Ingelheim Investigational Site, Nahariya, Israel|1218.17.97276 Boehringer Ingelheim Investigational Site, Safed, Israel|1218.17.97278 Boehringer Ingelheim Investigational Site, Tel Aviv, Israel|1218.17.52007 Boehringer Ingelheim Investigational Site, Aguascalientes, Ags., Mexico|1218.17.52009 Boehringer Ingelheim Investigational Site, cOL OBREGON,León, Guanajuato, Mexico|1218.17.52003 Boehringer Ingelheim Investigational Site, Col. Lomas de San Francisco, Monterrey, Mexico|1218.17.52001 Boehringer Ingelheim Investigational Site, Col. Mitras Centro, Monterrey, N.L., Mexico|1218.17.52010 Boehringer Ingelheim Investigational Site, Col.Americana, Guadalajara, Jalisco, Mexico|1218.17.52005 Boehringer Ingelheim Investigational Site, Colonia Reforma Social, Mexico|1218.17.52008 Boehringer Ingelheim Investigational Site, Colonia Tlalpan, mexico, Mexico|1218.17.52006 Boehringer Ingelheim Investigational Site, Faccionamiento Lomas de Campestre,AGUASCAL, Mexico|1218.17.52002 Boehringer Ingelheim Investigational Site, Mexico, Mexico|1218.17.52004 Boehringer Ingelheim Investigational Site, Tlalpan-México D,F, Mexico|1218.17.64004 Boehringer Ingelheim Investigational Site, Christchurch, New Zealand|1218.17.64003 Boehringer Ingelheim Investigational Site, Dunedin, New Zealand|1218.17.64002 Boehringer Ingelheim Investigational Site, Otahuhu, New Zealand|1218.17.64001 Boehringer Ingelheim Investigational Site, Tauranga, New Zealand|1218.17.64005 Boehringer Ingelheim Investigational Site, Wellington, New Zealand|1218.17.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.17.70002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.17.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.17.70005 Boehringer Ingelheim Investigational Site, Novosibirsk, Russian Federation|1218.17.70006 Boehringer Ingelheim Investigational Site, Perm, Russian Federation|1218.17.70004 Boehringer Ingelheim Investigational Site, Tomsk, Russian Federation|1218.17.46013 Boehringer Ingelheim Investigational Site, Härnösand, Sweden|1218.17.46001 Boehringer Ingelheim Investigational Site, Malmö, Sweden|1218.17.46012 Boehringer Ingelheim Investigational Site, Uddevalla, Sweden|1218.17.46004 Boehringer Ingelheim Investigational Site, Uppsala, Sweden|1218.17.46015 Boehringer Ingelheim Investigational Site, Uppsala, Sweden
URL: https://clinicaltrials.gov/show/NCT00601250

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress