Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01874483
Start Date
June 1 2013
End Date
December 1 2013
Last Update
January 27 2016
Active Locations (1)
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1
1307.2.1 Boehringer Ingelheim Investigational Site
Neuss, Germany