| Outcome Measures: |
Primary: HbA1c Change From Baseline at Week 12, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 12 | Secondary: HbA1c Change From Baseline at Week 52, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 52|HbA1c Change From Baseline at Week 18, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 18|HbA1c Change From Baseline at Week 24, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 24|HbA1c Change From Baseline at Week 30, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 30|HbA1c Change From Baseline at Week 36, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 36|HbA1c Change From Baseline at Week 42, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 42|HbA1c Change From Baseline at Week 48, HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication., Baseline and Week 48|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment, The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=6.5%, Baseline and Week 52|The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment, The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=7%., Baseline and Week 52|Percentage of Patients With HbA1c Lowering by 0.5% at Week 52, The percentage of patients with an HbA1c reduction from baseline \>=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF)., Baseline and Week 52|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 continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs, Baseline and Week 12|FPG Change From Baseline at Week 18, Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs, 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 continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs, Baseline and Week 24|FPG Change From Baseline at Week 30, This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs, Baseline and Week 30|FPG Change From Baseline at Week 36, This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs, Baseline and Week 36|FPG Change From Baseline at Week 42, This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs, Baseline and Week 42|FPG Change From Baseline at Week 48, This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs, Baseline and Week 48|FPG Change From Baseline at week52, This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs, Baseline and Week 52|Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time, Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin., Baseline and Week 52|Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG, Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events., first administration of randomised treatment to ....
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| Locations: |
1218.43.10027 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States|1218.43.10011 Boehringer Ingelheim Investigational Site, Chula Vista, California, United States|1218.43.10006 Boehringer Ingelheim Investigational Site, Riverside, California, United States|1218.43.10021 Boehringer Ingelheim Investigational Site, Whittier, California, United States|1218.43.10013 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States|1218.43.10009 Boehringer Ingelheim Investigational Site, West Palm Beach, Florida, United States|1218.43.10018 Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States|1218.43.10022 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.43.10015 Boehringer Ingelheim Investigational Site, Shreveport, Louisiana, United States|1218.43.10016 Boehringer Ingelheim Investigational Site, Kansas City, Missouri, United States|1218.43.10004 Boehringer Ingelheim Investigational Site, Bronx, New York, United States|1218.43.10003 Boehringer Ingelheim Investigational Site, Great Neck, New York, United States|1218.43.10020 Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States|1218.43.10019 Boehringer Ingelheim Investigational Site, Delaware, Ohio, United States|1218.43.10008 Boehringer Ingelheim Investigational Site, Mentor, Ohio, United States|1218.43.10005 Boehringer Ingelheim Investigational Site, Bethlehem, Pennsylvania, United States|1218.43.10007 Boehringer Ingelheim Investigational Site, Carlisle, Pennsylvania, United States|1218.43.10001 Boehringer Ingelheim Investigational Site, Providence, Rhode Island, United States|1218.43.10025 Boehringer Ingelheim Investigational Site, Aiken, South Carolina, United States|1218.43.10023 Boehringer Ingelheim Investigational Site, Austin, Texas, United States|1218.43.10024 Boehringer Ingelheim Investigational Site, Austin, Texas, United States|1218.43.10014 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.43.10017 Boehringer Ingelheim Investigational Site, Lufkin, Texas, United States|1218.43.10010 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States|1218.43.61009 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia|1218.43.61010 Boehringer Ingelheim Investigational Site, Auchenflower, Queensland, Australia|1218.43.61006 Boehringer Ingelheim Investigational Site, Kippa Ring, Queensland, Australia|1218.43.61007 Boehringer Ingelheim Investigational Site, Reservoir, Victoria, Australia|1218.43.61011 Boehringer Ingelheim Investigational Site, Richmond, Victoria, Australia|1218.43.61005 Boehringer Ingelheim Investigational Site, Adelaide, SA, Australia|1218.43.61002 Boehringer Ingelheim Investigational Site, Herston, QLD, Australia|1218.43.85201 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1218.43.85203 Boehringer Ingelheim Investigational Site, New Territories, Hong Kong|1218.43.97008 Boehringer Ingelheim Investigational Site, Afula, Israel|1218.43.97005 Boehringer Ingelheim Investigational Site, Ashkelon, Israel|1218.43.97003 Boehringer Ingelheim Investigational Site, Haifa, Israel|1218.43.97004 Boehringer Ingelheim Investigational Site, Jerusalem, Israel|1218.43.97009 Boehringer Ingelheim Investigational Site, Jerusalem, Israel|1218.43.97002 Boehringer Ingelheim Investigational Site, Kfar Saba, Israel|1218.43.97007 Boehringer Ingelheim Investigational Site, Nahariya, Israel|1218.43.97001 Boehringer Ingelheim Investigational Site, Safed, Israel|1218.43.97006 Boehringer Ingelheim Investigational Site, Tel Aviv, Israel|1218.43.64001 Boehringer Ingelheim Investigational Site, Auckland, New Zealand|1218.43.64003 Boehringer Ingelheim Investigational Site, Christchurch, New Zealand|1218.43.64004 Boehringer Ingelheim Investigational Site, Takpuna, New Zealand|1218.43.64002 Boehringer Ingelheim Investigational Site, Tauranga, New Zealand|1218.43.38004 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine|1218.43.38003 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1218.43.38006 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1218.43.38005 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.43.38007 Boehringer Ingelheim Investigational Site, Lugansk, Ukraine|1218.43.38008 Boehringer Ingelheim Investigational Site, Ternopil, Ukraine|1218.43.38002 Boehringer Ingelheim Investigational Site, Zaporizhzhya, Ukraine
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