Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 187004 CL in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: BI 187004
* Drug: BI 187004
* Drug: BI 187004
* Drug: BI 187004
* Drug: BI 187004
* Drug: BI 187004
* Drug: BI 187004


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Type 2 diabetes mellitus Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues) Males or post-menopausal or surgically sterilised females Age from 20 and to 70 years HbA1c less or equal to 8.5% BMI 28-40 kg/m2 Subjects must be able to understand an comply with study requirements Exclusion criteria: Any finding in the medical examination (including BP, PR or ECG) deviating from normal that the investigator considers to be of not acceptable clinical relevance Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg 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 Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy Chronic or relevant acute infections (e.g. HIV, hepatitis)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 187004 dose 1<br>multiple dose given over 14 days | Drug: BI 187004<br>* BI 187004, dose 1<br>|
| Experimental: BI 187004 dose 2<br>multiple dose given over 14 days | Drug: BI 187004<br>* BI 187004, dose 2<br>|
| Experimental: BI 187004 dose 3<br>multiple dose given over 14 days | Drug: BI 187004<br>* BI 187004, dose 3<br>|
| Experimental: BI 187004 dose 4<br>multiple dose given over 14 days | Drug: BI 187004<br>* BI 187004, dose 4<br>|
| Experimental: BI 187004 dose 5<br>multiple dose given over 14 days | Drug: BI 187004<br>* BI 187004, dose 5<br>|
| Experimental: BI 187004 dose 6<br>multiple dose given over 14 days | Drug: BI 187004<br>* BI 187004, dose 6<br>|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br>* placebo<br>|
| Experimental: BI 187004 dose 7<br>multiple dose given over 14 days | Drug: BI 187004<br>* BI 187004, dose 7<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | up to 15 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) |  | up to 8 days postdose | 
| Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose) |  | up to 8 days postdose | 
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) |  | up to 8 days postdose | 
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) |  | up to 8 days postdose |