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

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ClinicalTrials.gov Identifier: NCT01547897
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
TME Pharma AG

Study Description
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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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Albuminuria Drug: NOX-E36 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Effect of NOX-E36 on hsCRP [ Time Frame: Change versus baseline after 12 weeks treatment ]
    Comparison of patients treated with NOX-E36 versus placebo

  2. Effect of NOX-E36 on HbA1C [ Time Frame: Change versus baseline after 12 weeks treatment ]
    Comparison of patients treated with NOX-E36 versus placebo

  3. 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

  4. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547897


Locations
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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
TME Pharma AG
Investigators
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Study Director: Kai Riecke, MD Noxxon AG
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: TME Pharma AG
ClinicalTrials.gov Identifier: NCT01547897    
Other Study ID Numbers: SNOXE36C301
2011-005710-11 ( EudraCT Number )
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: September 2013
Additional relevant MeSH terms:
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Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations