Clinical Trials Directory

Trials / Completed

CompletedNCT01681290

Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
250 (actual)
Sponsor
Cebix Incorporated · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).

Conditions

Interventions

TypeNameDescription
DRUGCBX129801

Timeline

Start date
2012-10-01
Primary completion
2014-11-01
Completion
2015-01-01
First posted
2012-09-07
Last updated
2015-01-30

Locations

29 sites across 3 countries: United States, Canada, Sweden

Source: ClinicalTrials.gov record NCT01681290. Inclusion in this directory is not an endorsement.