This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,549
Medium dose once daily
1-4 mg once daily
Placebo matching BI 10773
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.
Time frame: Baseline and 104 weeks
The Change in Body Weight From Baseline After 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Change From Baseline in HbA1c After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Change in Body Weight From Baseline After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
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Placebo matching Glimepiride
1245.28.10005 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.28.10012 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.28.10016 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
1245.28.10003 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
1245.28.10021 Boehringer Ingelheim Investigational Site
West Hills, California, United States
1245.28.10009 Boehringer Ingelheim Investigational Site
Bradednton, Florida, United States
1245.28.10015 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1245.28.10033 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia, United States
1245.28.10026 Boehringer Ingelheim Investigational Site
Boise, Idaho, United States
1245.28.10007 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
...and 172 more locations