| Trial ID: | L1835 |
| Source ID: | NCT00935220
|
| Associated Drug: |
Linagliptin Qd (Once Daily) For 7 Days
|
| Title: |
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00935220/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: linagliptin QD (once daily) for 7 days
|
| Outcome Measures: |
Primary: Linagliptin: AUC_τ,ss, area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval, 24 hours|Linagliptin: C_max,ss, maximum concentration of linagliptin in plasma at steady state, 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., One single measurement 24 h after drug administration under steady state conditions | Secondary: Treatment Emergent Adverse Events, Frequency of patients with AEs, 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, 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, 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, 24 hours|Linagliptin: C_max, maximum concentration of linagliptin in plasma on Day 1, 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., One single measurement 24 h after drug administration
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
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| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2009-06
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| Completion Date: |
|
| Results First Posted: |
2011-11-10
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| Last Update Posted: |
2014-06-27
|
| Locations: |
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
|
| URL: |
https://clinicaltrials.gov/show/NCT00935220
|
