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

NCT01547897 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-02-24

No results posted yet for this study

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

Conditions

Interventions

DRUG

NOX-E36

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

Sponsors & Collaborators

  • TME Pharma AG

    lead INDUSTRY

Principal Investigators

  • Kai Riecke, MD · Noxxon AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • Czechia
  • Germany
  • Hungary
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01547897 on ClinicalTrials.gov