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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2012

Last Updated Date

February 21, 2014

Start Date ^ICMJE

March 2012

Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01547897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 creatinie and cystatin C

Comparison of patients treated with NOX-E36 versus placebo

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes Mellitus
Albuminuria

Intervention ^ICMJE

Drug: NOX-E36

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

Study Arm (s)

Active Comparator: NOX-E36
Intervention: Drug: NOX-E36
Placebo Comparator: Placebo
Intervention: Drug: NOX-E36

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2013

Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Czech Republic, Germany, Hungary, Poland, Romania

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01547897

Other Study ID Numbers ^ICMJE

SNOXE36C301, 2011-005710-11

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

NOXXON Pharma AG

Study Sponsor ^ICMJE

NOXXON Pharma AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kai Riecke, MD

Noxxon AG

Information Provided By

NOXXON Pharma AG

Verification Date

September 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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