NCT01547897

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2012

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach
5 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 24, 2014

Status Verified

September 1, 2013

Enrollment Period

1.5 years

First QC Date

February 27, 2012

Last Update Submit

February 21, 2014

Conditions

Type 2 Diabetes MellitusAlbuminuria

Outcome Measures

Primary Outcomes (1)

  • Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)

    ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo

    Change versus baseline after 12 weeks treatment

Secondary Outcomes (4)

  • Effect of NOX-E36 on hsCRP

    Change versus baseline after 12 weeks treatment

  • Effect of NOX-E36 on HbA1C

    Change versus baseline after 12 weeks treatment

  • Effect of NOX-E36 on HOMA-IR

    Change versus baseline after 12 weeks treatment

  • Effect of NOX-E36 on eGFR

    Change versus baseline after 12 weeks treatment

Study Arms (2)

NOX-E36

ACTIVE COMPARATOR
Drug: NOX-E36

Placebo

PLACEBO COMPARATOR
Drug: NOX-E36

Interventions

NOX-E36DRUG

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

NOX-E36Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Aschaffenburg, Germany

Location

Unknown Facility

Dortmund, Germany

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Kronberg, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Unknown Facility

Offenbach, Germany

Location

Unknown Facility

Schwabenheim, Germany

Location

Unknown Facility

Witten, Germany

Location

Unknown Facility

Balatonfüred, Hungary

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Gyula, Hungary

Location

Unknown Facility

Miskolc, Hungary

Location

Unknown Facility

Pécs, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Grodzisk Mazowiecki, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Arad, Romania

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Timișoara, Romania

Location

Related Publications (1)

  • Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

    PMID: 30957581DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Albuminuria

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kai Riecke, MD

    Noxxon AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 8, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

February 24, 2014

Record last verified: 2013-09

Locations

CZ(1)PL(4)RO(3)HU(6)DE(10)