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

February 21, 2014 updated by: TME Pharma AG

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week
Active Comparator: NOX-E36
Drug: NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change versus baseline after 12 weeks treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of NOX-E36 on hsCRP
Time Frame: Change versus baseline after 12 weeks treatment
Comparison of patients treated with NOX-E36 versus placebo
Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on HbA1C
Time Frame: Change versus baseline after 12 weeks treatment
Comparison of patients treated with NOX-E36 versus placebo
Change versus baseline after 12 weeks treatment
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
Change versus baseline after 12 weeks treatment
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
Change versus baseline after 12 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TME Pharma AG

Investigators

  • Study Director: Kai Riecke, MD, Noxxon AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 21, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNOXE36C301
  • 2011-005710-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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