Clinical Trial: NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase IIa Study to Characterize the Effects of CCL2 Inhibition With the Spiegelmer® NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Brief Summary:
Primary objective:
- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria
Secondary objectives:
- To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)
- To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function
- To assess the safety and tolerability of study drug
- To determine the population pharmacokinetics (PK) of study drug
Detailed Summary:
Sponsor: NOXXON Pharma AG
Current Primary Outcome: Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g) [ Time Frame: Change versus baseline after 12 weeks treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Effect of NOX-E36 on hsCRP [ Time Frame: Change versus baseline after 12 weeks treatment ]Comparison of patients treated with NOX-E36 versus placebo
- Effect of NOX-E36 on HbA1C [ Time Frame: Change versus baseline after 12 weeks treatment ]Comparison of patients treated with NOX-E36 versus placebo
- Effect of NOX-E36 on HOMA-IR [ Time Frame: Change versus baseline after 12 weeks treatment ]Comparison of patients treated with NOX-E36 versus placebo
- Effect of NOX-E36 on eGFR [ Time Frame: Change versus baseline after 12 weeks treatment ]
eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C
Comparison of patients treated with NOX-E36 versus placebo
Original Secondary Outcome:
- Effect of NOX-E36 on hsCRP [ Time Frame: Change versus baseline after 12 weeks treatment ]Comparison of patients treated with NOX-E36 versus placebo
- Effect of NOX-E36 on HbA1C [ Time Frame: Change versus baseline after 12 weeks treatment ]Comparison of patients treated with NOX-E36 versus placebo
- Effect of NOX-E36 on HOMA-IR [ Time Frame: Change versus baseline after 12 weeks treatment ]Comparison of patients treated with NOX-E36 versus placebo
- Effect of NOX-E36 on eGFR [ Time Frame: Change versus baseline after 12 weeks treatment ]
eGFR will be calculated by the CKD-EPI equation using creatinie and cystatin C
Comparison of patients treated with NOX-E36 versus placebo
Information By: NOXXON Pharma AG
Dates:
Date Received: February 27, 2012
Date Started: March 2012
Date Completion:
Last Updated: February 21, 2014
Last Verified: September 2013