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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
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
Linagliptin: AUC_τ,ss
area under the concentration time curve (AUC\_τ) of linagliptin in plasma at steady state over a uniform dosing interval
Time frame: 24 hours
Linagliptin: C_max,ss
maximum concentration of linagliptin in plasma at steady state
Time frame: 24 hours
DPP-4 Inhibition: E_24,ss
Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))\*100%, where 'activity' is the activity of the DPP-IV enzyme.
Time frame: One single measurement 24 h after drug administration under steady state conditions
Treatment Emergent Adverse Events
Frequency of patients with AEs
Time frame: 21 days
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
Time frame: 21 days
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
Time frame: 21 days
Linagliptin: AUC_0-24
area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose
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1218.55.0003 Boehringer Ingelheim Investigational Site
New York, New York, United States
1218.55.0001 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
Time frame: 24 hours
Linagliptin: C_max
maximum concentration of linagliptin in plasma on Day 1
Time frame: 24h
DPP-4 Inhibition: E_24
Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))\*100%, where 'activity' is the activity of the DPP-IV enzyme.
Time frame: One single measurement 24 h after drug administration