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

Conditions: diabetes mellitus type II and albuminuria
MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.1Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-005710-11-HU

Lead Sponsor: OXXON Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1) Type 1 diabetes mellitus
2) eGFR =25 mL/min/1.73m2 (calculated by 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 (randomization) in this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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 Objective: • To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c) <br>• To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function <br>• To assess the safety and tolerability of study drug <br>• To determine the population pharmacokinetics (PK) of study drug;Primary end point(s): The primary efficacy parameter is the effect of study drug and placebo on the change in ACR (week 12, minues baseline).;Timepoint(s) of evaluation of this end point: Days -30 to -1, 1, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - ACR calculated in first morning void urine <br>- HbA1c and hsCRP in serum <br>- Homeostasis Model of Insulin Resistance (HOMA–IR) <br>- Changes in blood pressure as marker of cardiovascular function <br>- Further urine and serum/plasma markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function<br>- Flow cytometric determination of CCR2 positive leukocyte subsets in peripheral blood;Timepoint(s) of evaluation of this end point: -ACR: Days -30 to -1, 1, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169 <br>-hsCRP and HbA1c: Days -30 to -1, 1, 29, 57, 85, 113 <br>-HOMA-IR: Days 1, 85, 113 <br>- Further urine and serum/plasma markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function: Days 1, 29, 57, 85, 113 <br>- Changes in blood pressure:Days -30 to -1, 1, 29, 57, 85, 113

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