| Outcome Measures: |
Primary: 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, renal function impairment and prior use of antidiabetic agents., Baseline and week 12 | Secondary: HbA1c Change From Baseline Over Time, HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling., Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52|Fasting Plasma Glucose (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 prior use of insulin, week repeated within patient and week by treatment interaction., Baseline and week 12|Fasting Plasma Glucose (FPG) Change From Baseline Over Time, This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling., Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52|Percentage of Patients With HbA1c <7.0%, The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%., Baseline, week 12 and week 52|Percentage of Patients With HbA1c <6.5%, The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%., Baseline, week 12 and week 52|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%, The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%., Baseline, week 12 and week 52|Plasma Concentration of Linagliptin at Trough, Trough levels of concentration of Linagliptin in plasma., Week 12, 24 and 52
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| Locations: |
1218.64.10007 Boehringer Ingelheim Investigational Site, Chula Vista, California, United States|1218.64.10018 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States|1218.64.10016 Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States|1218.64.10015 Boehringer Ingelheim Investigational Site, Boise, Idaho, United States|1218.64.10002 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.64.10004 Boehringer Ingelheim Investigational Site, Flint, Michigan, United States|1218.64.10006 Boehringer Ingelheim Investigational Site, Kansas City, Missouri, United States|1218.64.10003 Boehringer Ingelheim Investigational Site, Bronx, New York, United States|1218.64.10013 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States|1218.64.10020 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States|1218.64.10008 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States|1218.64.10009 Boehringer Ingelheim Investigational Site, Arlington, Texas, United States|1218.64.10005 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.64.10011 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.64.10014 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.64.10010 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States|1218.64.61005 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia|1218.64.61001 Boehringer Ingelheim Investigational Site, Liverpool, New South Wales, Australia|1218.64.61002 Boehringer Ingelheim Investigational Site, St Leonards, New South Wales, Australia|1218.64.61003 Boehringer Ingelheim Investigational Site, Adelaide, South Australia, Australia|1218.64.61004 Boehringer Ingelheim Investigational Site, Reservoir, Victoria, Australia|1218.64.20008 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada|1218.64.20005 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.64.20007 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.64.20002 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1218.64.20009 Boehringer Ingelheim Investigational Site, Stayner, Ontario, Canada|1218.64.20004 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.64.20003 Boehringer Ingelheim Investigational Site, Point Claire, Quebec, Canada|1218.64.35804 Boehringer Ingelheim Investigational Site, Kokkola, Finland|1218.64.35803 Boehringer Ingelheim Investigational Site, Oulu, Finland|1218.64.35801 Boehringer Ingelheim Investigational Site, Turku, Finland|1218.64.97204 Boehringer Ingelheim Investigational Site, Ashkelon, Israel|1218.64.97207 Boehringer Ingelheim Investigational Site, Givatayim, Israel|1218.64.97203 Boehringer Ingelheim Investigational Site, Haifa, Israel|1218.64.97201 Boehringer Ingelheim Investigational Site, Jerusalem, Israel|1218.64.97202 Boehringer Ingelheim Investigational Site, Nahariya, Israel|1218.64.97206 Boehringer Ingelheim Investigational Site, Tel Aviv, Israel|1218.64.81005 Boehringer Ingelheim Investigational Site, Asahi, Chiba, Japan|1218.64.81006 Boehringer Ingelheim Investigational Site, Isesaki, Gunma, Japan|1218.64.81001 Boehringer Ingelheim Investigational Site, Meguro-ku, Tokyo, Japan|1218.64.81008 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.64.81007 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.64.81002 Boehringer Ingelheim Investigational Site, Shinjyuku-ku,Tokyo, Japan|1218.64.81004 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan|1218.64.81003 Boehringer Ingelheim Investigational Site, Suwa, Nagano, Japan|1218.64.64001 Boehringer Ingelheim Investigational Site, Otahuhu Auckland, New Zealand|1218.64.42102 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1218.64.42107 Boehringer Ingelheim Investigational Site, Kosice, Slovakia|1218.64.42109 Boehringer Ingelheim Investigational Site, Nitra, Slovakia|1218.64.42108 Boehringer Ingelheim Investigational Site, Trencin, Slovakia|1218.64.46003 Boehringer Ingelheim Investigational Site, Helsingborg, Sweden|1218.64.46002 Boehringer Ingelheim Investigational Site, Härnösand, Sweden
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