At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
linagliptin QD (once daily) for 7 daysdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating linagliptin QD (once daily) for 7 days for Diabetes Mellitus, Type 2. Completed, enrolled 41 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJul 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedJul 8, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.0 years ago
Interventions
linagliptin QD (once daily) for 7 daysdrug
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration