Back to resultsNOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Primary Purpose
Type 2 Diabetes Mellitus, Albuminuria
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NOX-E36
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
NOX-E36
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Effect of NOX-E36 on hsCRP
Comparison of patients treated with NOX-E36 versus placebo
Effect of NOX-E36 on HbA1C
Comparison of patients treated with NOX-E36 versus placebo
Effect of NOX-E36 on HOMA-IR
Comparison of patients treated with NOX-E36 versus placebo
Effect of NOX-E36 on eGFR
eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C
Comparison of patients treated with NOX-E36 versus placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01547897
Brief Title
NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TME Pharma AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Albuminuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NOX-E36
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NOX-E36
Intervention Description
0.5 mg/kg study drug or placebo as SC injections twice a week
Primary Outcome Measure Information:
Title
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)
Description
ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo
Time Frame
Change versus baseline after 12 weeks treatment
Secondary Outcome Measure Information:
Title
Effect of NOX-E36 on hsCRP
Description
Comparison of patients treated with NOX-E36 versus placebo
Time Frame
Change versus baseline after 12 weeks treatment
Title
Effect of NOX-E36 on HbA1C
Description
Comparison of patients treated with NOX-E36 versus placebo
Time Frame
Change versus baseline after 12 weeks treatment
Title
Effect of NOX-E36 on HOMA-IR
Description
Comparison of patients treated with NOX-E36 versus placebo
Time Frame
Change versus baseline after 12 weeks treatment
Title
Effect of NOX-E36 on eGFR
Description
eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C
Comparison of patients treated with NOX-E36 versus placebo
Time Frame
Change versus baseline after 12 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Riecke, MD
Organizational Affiliation
Noxxon AG
Official's Role
Study Director
Facility Information:
City
Praha
Country
Czech Republic
City
Aschaffenburg
Country
Germany
City
Dortmund
Country
Germany
City
Düsseldorf
Country
Germany
City
Hannover
Country
Germany
City
Kronberg
Country
Germany
City
Mainz
Country
Germany
City
Mannheim
Country
Germany
City
Offenbach
Country
Germany
City
Schwabenheim
Country
Germany
City
Witten
Country
Germany
City
Balatonfüred
Country
Hungary
City
Budapest
Country
Hungary
City
Gyula
Country
Hungary
City
Miskolc
Country
Hungary
City
Pecs
Country
Hungary
City
Szeged
Country
Hungary
City
Bialystok
Country
Poland
City
Grodzisk Mazowiecki
Country
Poland
City
Katowice
Country
Poland
City
Warszawa
Country
Poland
City
Arad
Country
Romania
City
Bucharest
Country
Romania
City
Timisoara
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
30957581
Citation
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.
Results Reference
derived
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NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
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