Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients

Inclusion criteria

• Glycosylated haemoglobin >=7 and <= 10%
• Age >=21 and <= 65
• Body Mass Index >=18.5 and <=38 kg/m2
• African American origin
• Signed and dated informed consent prior to admission to the study

Exclusion criteria

• Any finding of the medical examination considered clinically relevant by the Investigator
• Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension >160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).
• Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
• Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
• Diagnosis of sickle cell anemia or known chronic anemia
• History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)
• History of relevant allergy/hypersensitivity
• Intake of drugs with a long half life (>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication
• Alcohol abuse, drug abuse
• Any laboratory value of clinical relevance that is outside an acceptable range
• Change of drug dosing of allowed co medication
• Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
• Fasted glucose >270 mg/dl or randomly determined blood glucose >400 mg/dl on two consecutive days during screening or wash out
• Serum creatinine above upper limit normal at screening