Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin

Exclusion Criteria

• •1. Treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
• •2. Fasted plasma glucose \> 240 mg/dl (\>13.3 mmol/l) on two consecutive days after screening (Visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
• •3. Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
• •4. Any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
• •5. Medical history of cancer or treatment for cancer in the last five years prior to the Visit 1a.
• •6. History of Cushing syndrome, Addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome
• •7. Treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug.
• •8. Treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance.
• •9. Use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication.
• •10. Surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial
• •11. Any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. Smoking habits interfering with hospitalization. Patients not willing to abstain from alcoholic beverages during inpatient visits
• •12. Male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake