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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547897
• Other study ID #: SNOXE36C301
• Secondary ID: 2011-005710-11
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2012
• Last updated: February 21, 2014
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: NOXXON Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesRomania: National Medicines AgencyHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NOXXON Pharma AG

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change versus baseline after 12 weeks treatment	No
Secondary	Effect of NOX-E36 on hsCRP	Comparison of patients treated with NOX-E36 versus placebo	Change versus baseline after 12 weeks treatment	No
Secondary	Effect of NOX-E36 on HbA1C	Comparison of patients treated with NOX-E36 versus placebo	Change versus baseline after 12 weeks treatment	No
Secondary	Effect of NOX-E36 on HOMA-IR	Comparison of patients treated with NOX-E36 versus placebo	Change versus baseline after 12 weeks treatment	No
Secondary	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	Change versus baseline after 12 weeks treatment	Yes