Clinical Trial Details
| Trial ID: | L4060 |
| Source ID: | NCT01581658 |
| Associated Drug: | Bi10773 |
| Title: | Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01581658/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: BI10773|DRUG: BI10773|DRUG: BI10773|DRUG: BI10773 |
| Outcome Measures: | Primary: Change From Baseline in Total Urinary Glucose Excretion (UGE), change from baseline in total urinary glucose excretion (UGE) to 24 hours, baseline and 24 hours|Area Under the Concentration Time Curve of the Analyte in Plasma, Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity, Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Maximum Concentration, Maximum concentration of the analyte in plasma, Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration | |
| Sponsor/Collaborators: | Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 32 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-04-01 |
| Completion Date: | 2012-11-01 |
| Results First Posted: | 2014-06-17 |
| Last Update Posted: | 2017-08-14 |
| Locations: | 1245.53.001 Boehringer Ingelheim Investigational Site, Kurume, Fukuoka, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01581658 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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