Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
103
1307.4.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1307.4.49002 Boehringer Ingelheim Investigational Site
Mainz, Germany
1307.4.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany
The percentage of patients with drug- related adverse events
Time frame: 6 weeks
Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment
Time frame: 4 weeks
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