Clinical trial NCT00935220: Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 origin.


Eligibility criteria: 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

Primary outcomes:
measure: Linagliptin: AUC_τ,ss
timeFrame: 24 hours
measure: Linagliptin: C_max,ss
timeFrame: 24 hours
measure: DPP-4 Inhibition: E_24,ss
timeFrame: One single measurement 24 h after drug administration under steady state conditions
Secondary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: 21 days
measure: Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
timeFrame: 21 days
measure: Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
timeFrame: 21 days
measure: Linagliptin: AUC_0-24
timeFrame: 24 hours
measure: Linagliptin: C_max
timeFrame: 24h
measure: DPP-4 Inhibition: E_24
timeFrame: One single measurement 24 h after drug administration
Other outcomes:
Locations:
city: Cypress
country: United States
facility: 1218.55.0006 Boehringer Ingelheim Investigational Site
state: California
city: Deland
country: United States
facility: 1218.55.0008 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1218.55.0004 Boehringer Ingelheim Investigational Site
state: Florida
city: Baltimore
country: United States
facility: 1218.55.0005 Boehringer Ingelheim Investigational Site
state: Maryland
city: New York
country: United States
facility: 1218.55.0003 Boehringer Ingelheim Investigational Site
state: New York
city: Dallas
country: United States
facility: 1218.55.0001 Boehringer Ingelheim Investigational Site
state: Texas
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: