Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
245
Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18
HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Time frame: Baseline, week 18
Change From Baseline in Fasting Plasma Glucose at Week 18
Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Time frame: Baseline, week 18
Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18
An absolute efficacy response is defined as HbA1c \< 7.0% at 18 weeks. A non-response is defined as HbA1c \>= 7.0% at 18 weeks.
Time frame: week 18
Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18
An absolute efficacy response is defined as HbA1c \< 6.5% at 18 weeks. A non-response is defined as HbA1c \>= 6.5% at 18 weeks.
Time frame: week 18
Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18
An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.
Time frame: Baseline, week 18
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6
HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
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...and 35 more locations
Time frame: Baseline, week 6
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12
HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Time frame: Baseline, week 12
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18
HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Time frame: Baseline, week 18
Change From Baseline in Fasting Plasma Glucose at Week 6
Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Time frame: Baseline, week 6
Change From Baseline in Fasting Plasma Glucose at Week 12
Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Time frame: Baseline, week 12