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 ]

ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo


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