The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
986
placebo tablets once daily
BI 10773 low dose tablet once daily
Patients receive BI 10773 high dose tablets open label once daily
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Time frame: Baseline and day 169
Change From Baseline to Week 24 in Body Weight
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Time frame: Baseline and day 169
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.
Time frame: Baseline and week 24
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placebo tablets once daily
placebo tablets once daily
placebo tablets once daily
placebo tablets once daily
placebo tablets once daily
BI 10773 high dose tablets once daily
Sitagliptin tablets 100 mg once daily
placebo tablets once daily
placebo tablets once daily
placebo tablets once daily
1245.20.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1245.20.10108 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.20.10150 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
1245.20.10154 Boehringer Ingelheim Investigational Site
Chino, California, United States
1245.20.10009 Boehringer Ingelheim Investigational Site
Santa Ana, California, United States
1245.20.10131 Boehringer Ingelheim Investigational Site
West Hills, California, United States
1245.20.10038 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States
1245.20.10137 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1245.20.10006 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1245.20.10085 Boehringer Ingelheim Investigational Site
Plantation, Florida, United States
...and 114 more locations