An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days
- NCT00935220
- PHASE1
- INTERVENTIONAL
Last updated: 2014-06-27
Purpose of Trial
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 origin.
This study is for people with
Diabetes Mellitus, Type 2
Interventions being studied
linagliptin QD (once daily) for 7 days
Inclusion criteria:
1. Glycosylated haemoglobin \>=7 and \<= 10%
2. Age \>=21 and \<= 65
3. Body Mass Index \>=18.5 and \<=38 kg/m2
4. African American origin
5. Signed and dated informed consent prior to admission to the study
Exclusion criteria:
1. Any finding of the medical examination considered clinically relevant by the Investigator
2. 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).
3. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
4. Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
5. Diagnosis of sickle cell anemia or known chronic anemia
6. History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)
7. History of relevant allergy/hypersensitivity
8. 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
9. Alcohol abuse, drug abuse
10. Any laboratory value of clinical relevance that is outside an acceptable range
11. Change of drug dosing of allowed co medication
12. Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
13. Fasted glucose \>270 mg/dl or randomly determined blood glucose \>400 mg/dl on two consecutive days during screening or wash out
14. Serum creatinine above upper limit normal at screening
ELIGIBILITY
Gender: ALL
Age: 21+
Healthy Volunteers: No
6 Locations
Cypress
1218.55.0006 Boehringer Ingelheim Investigational Site
California, United States
Deland
1218.55.0008 Boehringer Ingelheim Investigational Site
Florida, United States
Miami
1218.55.0004 Boehringer Ingelheim Investigational Site
Florida, United States
Baltimore
1218.55.0005 Boehringer Ingelheim Investigational Site
Maryland, United States
New York
1218.55.0003 Boehringer Ingelheim Investigational Site
New York, United States
Dallas
1218.55.0001 Boehringer Ingelheim Investigational Site
Texas, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov