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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus; Albuminuria
• Interventions: Drug: NOX-E36

• Registration Number: NCT01547897
• Lead Sponsor: TME Pharma AG

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 available

Study Timeline

• Study First Submitted: 2012-02-27
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Last Update Submitted: 2014-02-21
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NOX-E36	NOX-E36	-
Placebo	NOX-E36	-

Primary Outcome Measures

Name	Time	Method
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)	Change versus baseline after 12 weeks treatment	ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo

Secondary Outcome Measures

Name	Time	Method
Effect of NOX-E36 on hsCRP	Change versus baseline after 12 weeks treatment	Comparison of patients treated with NOX-E36 versus placebo
Effect of NOX-E36 on HbA1C	Change versus baseline after 12 weeks treatment	Comparison of patients treated with NOX-E36 versus placebo
Effect of NOX-E36 on HOMA-IR	Change versus baseline after 12 weeks treatment	Comparison of patients treated with NOX-E36 versus placebo
Effect of NOX-E36 on eGFR	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