Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00935220
Start Date
June 1 2009
Last Update
June 27 2014
Active Locations (6)
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1
1218.55.0006 Boehringer Ingelheim Investigational Site
Cypress, California, United States
2
1218.55.0008 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
3
1218.55.0004 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
4
1218.55.0005 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States