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

• ClinicalTrials.gov Identifier: NCT01547897
• Recruitment Status: Completed
• First Posted: March 8, 2012
• Last Update Posted: February 24, 2014
• Sponsor: TME Pharma AG
• Information provided by (Responsible Party): TME Pharma AG

Tracking Information

• First Submitted Date: February 27, 2012
• First Posted Date: March 8, 2012
• Last Update Posted Date: February 24, 2014
• Study Start Date: March 2012
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 5, 2012)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 25, 2013)

• Effect of NOX-E36 on hsCRP [ Time Frame: Change versus baseline after 12 weeks treatment ]
  Comparison of patients treated with NOX-E36 versus placebo
• Effect of NOX-E36 on HbA1C [ Time Frame: Change versus baseline after 12 weeks treatment ]
  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 ]
  Comparison of patients treated with NOX-E36 versus placebo
• 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

Original Secondary Outcome Measures (submitted: March 5, 2012)

• Effect of NOX-E36 on hsCRP [ Time Frame: Change versus baseline after 12 weeks treatment ]
  Comparison of patients treated with NOX-E36 versus placebo
• Effect of NOX-E36 on HbA1C [ Time Frame: Change versus baseline after 12 weeks treatment ]
  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 ]
  Comparison of patients treated with NOX-E36 versus placebo
• 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 creatinie and cystatin C Comparison of patients treated with NOX-E36 versus placebo

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Type 2 Diabetes Mellitus
• Albuminuria

Intervention

Drug: NOX-E36

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

Study Arms

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 21, 2014): 76
• Original Estimated Enrollment (submitted: March 5, 2012): 75
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czech Republic, Germany, Hungary, Poland, Romania

Administrative Information

• NCT Number: NCT01547897
• Other Study ID Numbers: SNOXE36C301; 2011-005710-11 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: TME Pharma AG
• Original Responsible Party: Same as current
• Current Study Sponsor: TME Pharma AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Kai Riecke, MD; Noxxon AG

• PRS Account: TME Pharma AG
• Verification Date: September 2013