Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00935220

Run by

Boehringer Ingelheim

People needed

41

Starts

2009-06-01

Last updated by the study team

2014-06-27

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1218.55.0006 Boehringer Ingelheim Investigational Site — Cypress, California, United States
• 1218.55.0008 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 1218.55.0004 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1218.55.0005 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 1218.55.0003 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 1218.55.0001 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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