Trials / Completed
CompletedNCT01547897
NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- TME Pharma AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | NOX-E36 | 0.5 mg/kg study drug or placebo as SC injections twice a week |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2013-09-01
- Completion
- 2013-12-01
- First posted
- 2012-03-08
- Last updated
- 2014-02-24
Locations
24 sites across 5 countries: Czechia, Germany, Hungary, Poland, Romania
Source: ClinicalTrials.gov record NCT01547897. Inclusion in this directory is not an endorsement.