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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NOXXON Pharma AG
ClinicalTrials.gov Identifier:
NCT01547897
First received: February 27, 2012
Last updated: February 21, 2014
Last verified: September 2013

February 27, 2012
February 21, 2014
March 2012
September 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo
Same as current
Complete list of historical versions of study NCT01547897 on ClinicalTrials.gov Archive Site
  • Effect of NOX-E36 on hsCRP [ Time Frame: Change versus baseline after 12 weeks treatment ] [ Designated as safety issue: No ]
    Comparison of patients treated with NOX-E36 versus placebo
  • Effect of NOX-E36 on HbA1C [ Time Frame: Change versus baseline after 12 weeks treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Comparison of patients treated with NOX-E36 versus placebo
  • Effect of NOX-E36 on eGFR [ Time Frame: Change versus baseline after 12 weeks treatment ] [ Designated as safety issue: Yes ]

    eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C

    Comparison of patients treated with NOX-E36 versus placebo

  • Effect of NOX-E36 on hsCRP [ Time Frame: Change versus baseline after 12 weeks treatment ] [ Designated as safety issue: No ]
    Comparison of patients treated with NOX-E36 versus placebo
  • Effect of NOX-E36 on HbA1C [ Time Frame: Change versus baseline after 12 weeks treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Comparison of patients treated with NOX-E36 versus placebo
  • Effect of NOX-E36 on eGFR [ Time Frame: Change versus baseline after 12 weeks treatment ] [ Designated as safety issue: Yes ]

    eGFR will be calculated by the CKD-EPI equation using creatinie and cystatin C

    Comparison of patients treated with NOX-E36 versus placebo

Not Provided
Not Provided
 
NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Albuminuria
Drug: NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week
  • Active Comparator: NOX-E36
    Intervention: Drug: NOX-E36
  • Placebo Comparator: Placebo
    Intervention: Drug: NOX-E36
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
December 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Romania,   Hungary,   Poland,   Czech Republic
 
NCT01547897
SNOXE36C301, 2011-005710-11
No
NOXXON Pharma AG
NOXXON Pharma AG
Not Provided
Study Director: Kai Riecke, MD Noxxon AG
NOXXON Pharma AG
September 2013

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