The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
333
Linagliptin medium dose tablet once daily
Linagliptin high dose tablet once daily
Linagliptin low dose tablet once daily
Placebo tablets once daily
Glimepiride tablets once daily
1218.6.3302A Boehringer Ingelheim Investigational Site
Joué Les Tours, France
1218.6.3303A Boehringer Ingelheim Investigational Site
Joué Les Tours, France
1218.6.3304A Boehringer Ingelheim Investigational Site
Joué-lès-Tours, France
1218.6.3305A Euraxi Pharma
Joué-lès-Tours, France
1218.6.3301A Boehringer Ingelheim Investigational Site
Paris, France
HbA1c Change From Baseline at Week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
Time frame: Baseline and week 12
Percentage of Patients With HbA1c<=7.0% at Week 12
Descriptive calculation of Patients with HbA1c \<= 7.0% at Week 12.
Time frame: week 12
Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Time frame: Baseline and week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1218.6.49007 Boehringer Ingelheim Investigational Site
Aschaffenburg, Germany
1218.6.49013 Boehringer Ingelheim Investigational Site
Bosenheim, Germany
1218.6.49008 Boehringer Ingelheim Investigational Site
Dresden, Germany
1218.6.49009 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1218.6.49014 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
...and 38 more locations