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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
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes Mellitus
Albuminuria
Drug: NOX-E36
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NOXXON Pharma AG:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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



Enrollment: 76
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NOX-E36 Drug: NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week
Placebo Comparator: Placebo Drug: NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547897

Locations
Czech Republic
Praha, Czech Republic
Germany
Aschaffenburg, Germany
Dortmund, Germany
Düsseldorf, Germany
Hannover, Germany
Kronberg, Germany
Mainz, Germany
Mannheim, Germany
Offenbach, Germany
Schwabenheim, Germany
Witten, Germany
Hungary
Balatonfüred, Hungary
Budapest, Hungary
Gyula, Hungary
Miskolc, Hungary
Pecs, Hungary
Szeged, Hungary
Poland
Bialystok, Poland
Grodzisk Mazowiecki, Poland
Katowice, Poland
Warszawa, Poland
Romania
Arad, Romania
Bucharest, Romania
Timisoara, Romania
Sponsors and Collaborators
NOXXON Pharma AG
Investigators
Study Director: Kai Riecke, MD Noxxon AG
  More Information

No publications provided

Responsible Party: NOXXON Pharma AG
ClinicalTrials.gov Identifier: NCT01547897     History of Changes
Other Study ID Numbers: SNOXE36C301, 2011-005710-11
Study First Received: February 27, 2012
Last Updated: February 21, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 24, 2014