| Trial ID: | L6469 |
| Source ID: | NCT01874483
|
| Associated Drug: |
Placebo
|
| Title: |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Placebo|DRUG: BI 187004|DRUG: BI 187004|DRUG: BI 187004|DRUG: BI 187004|DRUG: BI 187004|DRUG: BI 187004|DRUG: BI 187004
|
| Outcome Measures: |
Primary: Occurrence of adverse events, up to 15 days postdose | Secondary: AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose), up to 8 days postdose|Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose), up to 8 days postdose|AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t), up to 8 days postdose|Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t), up to 8 days postdose
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
71
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06
|
| Completion Date: |
2013-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-01-27
|
| Locations: |
1307.2.1 Boehringer Ingelheim Investigational Site, Neuss, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01874483
|
