Safety, Tolerability, Pharmacokinetics and Pharmacodynami... | NCT01282970

ID	Type	Description	Link
2010-022698-32	EudraCT Number	EudraCT

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 135585	Experimental	once daily doses as oral solution or tablet formulation over 14 days	Drug: BI 135585
Placebo to BI 135585	Placebo Comparator	once daily doses as oral solution or tablet formulation over 14 days	Drug: Placebo to BI 135585

Name	Type	Description	Arm Group Labels	Other Names
BI 135585	Drug	oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days	BI 135585

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of BI 135585 will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, electrocardiograms, laboratory tests, and incidence and severity of adverse events.		up to 16 days post treatment

Secondary Outcomes

Measure	Description	Time Frame
Assessment of Pharmacokinetic parameter Cmax (maximum measured concentration of the analyte in plasma) of BI 135585 following single and multiple dose oral administration		up to 10 days post treatment
Assessment of Pharmacokinetic parameter tmax (time from dosing to maximum measured concentration) of BI 135585 following single and multiple dose oral administration

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Male and postmenopausal or surgically sterilised female patients with an established diagnosis of type 2 diabetes mellitus prior to informed consent
Antidiabetic treatment with diet and exercise alone or with not more than one oral hypoglycaemic drug except glitazones, glucagon-like peptide 1 (GLP-1) analogues or dipeptidyl-peptidase 4 (DPP-4) inhibitors.
Antidiabetic treatment unchanged for 12 weeks prior to informed consent
Glycosylated haemoglobin A1 (HbA1c) ≤ 8.5% at screening
Age ≥ 20 and age ≤ 70 years
BMI ≥ 25 and BMI ≤ 40 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of not acceptable clinical relevance
Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
Gastrointestinal tract surgery that might affect absorption and elimination of drugs
Diseases of the central nerve system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
Chronic or relevant acute infections (e.g. HIV, hepatitis)
History of allergy/hypersensitivity (including allergy to drug or its excipients) that are deemed relevant to subject's safety or the trial by the investigator
Intake of drugs with a long half-life (> 24 hours) within one month prior to administration of the trial drug except for allowed co-medication
Treatment with glitazones, GLP-1 analogues, insulin, DPP-4 inhibitors, systemic or inhaled glucocorticoids, or anti-obesity drugs (e.g. orlistat) within 12 weeks prior to informed consent
Sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin, verapamil, budesonide, buspirone, eplerenone , eletriptan, felodipine, fluticasone, midazolam, saquinavir, sildenafil, vardenafil) or CYP3A4 substrates with narrow therapeutic range (e.g. cyclosporine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) or drugs that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to first administration of the trial drug
other exclusion criteria apply.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases