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Completed

NCT Number: NCT01547897

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

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Key information

Conditions

Type 2 Diabetes Mellitus Albuminuria Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition
  • Age ≥ 18
  • HbA1c between 6.0% and 10.5%, inclusive
  • ACR > 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements > 100 mg/g
  • Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia
  • Stable treatment with angiotensin-converting enzyme inhibitors (ACEi) and/or Angiotensin II receptor blockers (ARBs) (renin-angiotensin system [RAS] blockade)
  • Willing and able to understand and sign an approved Informed Consent form
  • 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

  • Type 1 diabetes mellitus
  • Estimated Glomerular Filtration Rate (eGFR) ≤25 mL/min/1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
  • Recent cardiovascular events (3 months)
  • Uncontrolled hypertension (upper limits 180/110 mmHg)
  • Dialysis and/or acute kidney injury within 3 months before screening
  • Significant edema, infectious diseases, leg ulcers
  • Severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study
  • Treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit
  • Patient with known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
  • In the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit
  • 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
  • In the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study.
  • Previous participation in this study.

Treatment and study plan

NOX-E36

Drug

0.5 mg/kg study drug or placebo as SC injections twice a week

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

TME Pharma AG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2012
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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