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Clinical Trial Details

Trial ID: L6942
Source ID: NCT01547897
Associated Drug: Nox-E36
Title: NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Albuminuria
Interventions: DRUG: NOX-E36
Outcome Measures: Primary: Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g), ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo, Change versus baseline after 12 weeks treatment | Secondary: Effect of NOX-E36 on hsCRP, Comparison of patients treated with NOX-E36 versus placebo, Change versus baseline after 12 weeks treatment|Effect of NOX-E36 on HbA1C, Comparison of patients treated with NOX-E36 versus placebo, Change versus baseline after 12 weeks treatment|Effect of NOX-E36 on HOMA-IR, Comparison of patients treated with NOX-E36 versus placebo, Change versus baseline after 12 weeks treatment|Effect of NOX-E36 on eGFR, eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C Comparison of patients treated with NOX-E36 versus placebo, Change versus baseline after 12 weeks treatment
Sponsor/Collaborators: Sponsor: TME Pharma AG
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 76
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-03
Completion Date: 2013-12
Results First Posted:
Last Update Posted: 2014-02-24
Locations: Praha, Czech Republic|Aschaffenburg, Germany|Dortmund, Germany|Düsseldorf, Germany|Hannover, Germany|Kronberg, Germany|Mainz, Germany|Mannheim, Germany|Offenbach, Germany|Schwabenheim, Germany|Witten, Germany|Balatonfüred, Hungary|Budapest, Hungary|Gyula, Hungary|Miskolc, Hungary|Pecs, Hungary|Szeged, Hungary|Bialystok, Poland|Grodzisk Mazowiecki, Poland|Katowice, Poland|Warszawa, Poland|Arad, Romania|Bucharest, Romania|Timisoara, Romania
URL: https://clinicaltrials.gov/show/NCT01547897

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress