The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
121
1218.37.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1218.37.49002 Boehringer Ingelheim Investigational Site
Mainz, Germany
1218.37.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany
Weighted Mean Glucose (WMG) Change From Baseline at Day 28
The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.
Time frame: Baseline and day 28
GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28
The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.
Time frame: Baseline and day 28
Fasting Plasma Glucose (FPG) Change From Baseline at Day 28
The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.
Time frame: Baseline and day 28
Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28
The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).
Time frame: Baseline and day 28
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once daily for 28 days
once daily for 28 days
5mg once daily for 28 days