Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01547897
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
NOXXON Pharma AG

Tracking Information
First Submitted Date  ICMJE February 27, 2012
First Posted Date  ICMJE March 8, 2012
Last Update Posted Date February 24, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
  • 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 Measures  ICMJE
 (submitted: March 5, 2012)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Albuminuria
Intervention  ICMJE Drug: NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week
Study Arms  ICMJE
  • Active Comparator: NOX-E36
    Intervention: Drug: NOX-E36
  • Placebo Comparator: Placebo
    Intervention: Drug: NOX-E36
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2014)
76
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2012)
75
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition
  2. Age ≥ 18
  3. HbA1c between 6.0% and 10.5%, inclusive
  4. ACR > 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements > 100 mg/g
  5. Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia
  6. Stable treatment with angiotensin-converting enzyme inhibitors (ACEi) and/or Angiotensin II receptor blockers (ARBs) (renin-angiotensin system [RAS] blockade)
  7. Willing and able to understand and sign an approved Informed Consent form
  8. Men must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Women must be of non-childbearing potential.

Exclusion Criteria:

  1. Type 1 diabetes mellitus
  2. Estimated Glomerular Filtration Rate (eGFR) ≤25 mL/min/1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
  3. Recent cardiovascular events (3 months)
  4. Uncontrolled hypertension (upper limits 180/110 mmHg)
  5. Dialysis and/or acute kidney injury within 3 months before screening
  6. Significant edema, infectious diseases, leg ulcers
  7. Severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study
  8. Treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit
  9. Patient with known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
  10. In the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit
  11. Use of thiazolidinedione class drugs, immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors, two or more diuretic drugs and/or aliskiren
  12. In the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study.
  13. Previous participation in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Hungary,   Poland,   Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547897
Other Study ID Numbers  ICMJE SNOXE36C301
2011-005710-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NOXXON Pharma AG
Study Sponsor  ICMJE NOXXON Pharma AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kai Riecke, MD Noxxon AG
PRS Account NOXXON Pharma AG
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP