Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria: Inclusion_Criteria: Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug HbA1c 7.5 10.0% at screening for patients treated with metformin alone HbA1c 7.5 10.0% at beginning of the placebo run-in phase Age > 21 and < 75 years MI > 25 and < 40 kg/m2 (Body Mass Index) Exclusion criteria: Exclusion_Criteria: Clinically relevant cardiovascular disease Impaired hepatic function Renal insufficiency or impaired renal function Treatment with rosiglitazone or pioglitazone within 6 months prior to screening Treatment with insulin within 3 months prior to screening
Sites / Locations
- 1218.6.3304A Boehringer Ingelheim Investigational Site
- 1218.6.3305A Euraxi Pharma
- 1218.6.3302A Boehringer Ingelheim Investigational Site
- 1218.6.3303A Boehringer Ingelheim Investigational Site
- 1218.6.3301A Boehringer Ingelheim Investigational Site
- 1218.6.49007 Boehringer Ingelheim Investigational Site
- 1218.6.49013 Boehringer Ingelheim Investigational Site
- 1218.6.49008 Boehringer Ingelheim Investigational Site
- 1218.6.49009 Boehringer Ingelheim Investigational Site
- 1218.6.49014 Boehringer Ingelheim Investigational Site
- 1218.6.49012 Boehringer Ingelheim Investigational Site
- 1218.6.49001 Boehringer Ingelheim Investigational Site
- 1218.6.49005 Boehringer Ingelheim Investigational Site
- 1218.6.49017 Boehringer Ingelheim Investigational Site
- 1218.6.49002 Boehringer Ingelheim Investigational Site
- 1218.6.49011 Boehringer Ingelheim Investigational Site
- 1218.6.49010 Boehringer Ingelheim Investigational Site
- 1218.6.49015 Boehringer Ingelheim Investigational Site
- 1218.6.49016 Boehringer Ingelheim Investigational Site
- 1218.6.49003 Boehringer Ingelheim Investigational Site
- 1218.6.42103 Boehringer Ingelheim Investigational Site
- 1218.6.42104 Boehringer Ingelheim Investigational Site
- 1218.6.42105 Boehringer Ingelheim Investigational Site
- 1218.6.42101 Boehringer Ingelheim Investigational Site
- 1218.6.46003 Boehringer Ingelheim Investigational Site
- 1218.6.46001 Boehringer Ingelheim Investigational Site
- 1218.6.46002 Boehringer Ingelheim Investigational Site
- 1218.6.46004 Boehringer Ingelheim Investigational Site
- 1218.6.38002 Boehringer Ingelheim Investigational Site
- 1218.6.38001 Boehringer Ingelheim Investigational Site
- 1218.6.38003 Boehringer Ingelheim Investigational Site
- 1218.6.38005 Boehringer Ingelheim Investigational Site
- 1218.6.44012 Boehringer Ingelheim Investigational Site
- 1218.6.44004 Boehringer Ingelheim Investigational Site
- 1218.6.44002 Boehringer Ingelheim Investigational Site
- 1218.6.44003 Boehringer Ingelheim Investigational Site
- 1218.6.44013 Boehringer Ingelheim Investigational Site
- 1218.6.44016 Boehringer Ingelheim Investigational Site
- 1218.6.44007 Boehringer Ingelheim Investigational Site
- 1218.6.44006 Boehringer Ingelheim Investigational Site
- 1218.6.44005 Boehringer Ingelheim Investigational Site
- 1218.6.44015 Boehringer Ingelheim Investigational Site
- 1218.6.44008 Boehringer Ingelheim Investigational Site
- 1218.6.44017 Boehringer Ingelheim Investigational Site
- 1218.6.44001 Boehringer Ingelheim Investigational Site
- 1218.6.44018 Boehringer Ingelheim Investigational Site
- 1218.6.44009 Boehringer Ingelheim Investigational Site
- 1218.6.44019 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Linagliptin low dose
Linagliptin medium dose
Linagliptin high dose
Placebo
Glimepiride
Patients receive Linagliptin low dose tablets once daily
Patients receive Linagliptin medium dose tablets once daily
Patients receive Linagliptin high dose tablets once daily
Patients receive tablets identical to those containing Linagliptin low, medium and high dose
Patients receive Glimepiride tablets once daily