This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,705
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks
Time frame: Baseline and 52 weeks
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Change from baseline in HbA1c after 76 weeks
Time frame: Baseline and 76 weeks
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
Time frame: Baseline and 76 weeks
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Systolic blood pressure - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Systolic blood pressure - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Diastolic blood pressure - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Diastolic blood pressure - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks
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Placebo matching Sitagliptin
Placebo matching BI 10773 high dose
Placebo matching BI 10773 high dose
BI 10773 tablets once daily
Placebo matching BI 10773 low dose
Placebo matching BI 10773 low dose
BI 10773 tablets once daily
Placebo matching BI 10773 low dose
Placebo matching BI 10773 high dose
Placebo matching Sitagliptin
BI 10773 tablets once daily
BI 10773 tablets once daily
BI 10773 tablets once daily
Placebo matching BI 10773 high dose
BI 10773 tablets once daily
Placebo matching BI 10773 low dose
Placebo matching BI 10773 high dose
Placebo matching Sitagliptin
Sitagliptin once daily
BI 10773 tablets once daily
Placebo matching BI 10773 low dose
Placebo matching BI 10773 low dose
Placebo matching BI 10773 low dose
Placebo matching BI 10773 high dose
Placebo matching BI 10773 low dose
Placebo matching BI 10773 high dose
Placebo matching BI 10773 high dose
1245.31.10145 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1245.31.10162 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
1245.31.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1245.31.10108 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.31.10046 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
1245.31.10154 Boehringer Ingelheim Investigational Site
Chino, California, United States
1245.31.10149 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California, United States
1245.31.10131 Boehringer Ingelheim Investigational Site
West Hills, California, United States
1245.31.10038 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States
1245.31.10127 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
...and 233 more locations
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Waist circumference (cm) - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Waist circumference (cm) - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
Fasting plasma glucose - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment
Fasting plasma glucose - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks