Clinical Trial Details
| Trial ID: | L3832 |
| Source ID: | NCT01551381 |
| Associated Drug: | Ev-077 |
| Title: | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EV-077 in Type 2 Diabetic Subjects |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: EV-077|DRUG: Placebo |
| Outcome Measures: | Primary: Platelet aggregation, Measured at Day 8 by Multiplate® with arachidonic acid as the agonist, 8 days | Secondary: Platelet aggregation, Measured at multiple time points by Multiplate (using arachidonic acid, collagen, U-46619 and ADP as agonists) and the Born method (using arachidonic acid, collagen and ADP as agonists), Days 1, 2, 8, 15, 22 and 29|Vascular inflammatory state, Changes from baseline in markers of platelet function, vascular function, vascular inflammation and vascular oxidative stress, Baseline, 2 weeks and 4 weeks|Diabetic state, Change from baseline in fasting plasma glucose and HbA1c, Baseline, 2 weeks and 4 weeks|Renal function, Change from baseline in urinary albumin excretion, creatinine clearance and exercise-induced microalbuminuria, Baseline, 2 weeks and 4 weeks |
| Sponsor/Collaborators: | Sponsor: Evolva SA |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 33 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-01 |
| Completion Date: | 2012-05 |
| Results First Posted: | |
| Last Update Posted: | 2013-06-17 |
| Locations: | Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany |
| URL: | https://clinicaltrials.gov/show/NCT01551381 |
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