Clinical trial NCT01547897: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Albuminuria
Lead sponsor: TME Pharma AG
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)
timeFrame: Change versus baseline after 12 weeks treatment
Secondary outcomes:
measure: Effect of NOX-E36 on hsCRP
timeFrame: Change versus baseline after 12 weeks treatment
measure: Effect of NOX-E36 on HbA1C
timeFrame: Change versus baseline after 12 weeks treatment
measure: Effect of NOX-E36 on HOMA-IR
timeFrame: Change versus baseline after 12 weeks treatment
measure: Effect of NOX-E36 on eGFR
timeFrame: Change versus baseline after 12 weeks treatment
Other outcomes:
Locations:
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
Study officials:
affiliation: Noxxon AG
name: Kai Riecke, MD
role: STUDY_DIRECTOR
References:
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.