Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

NCT01681290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-01-30

No results posted yet for this study

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

  • Diabetic Peripheral Neuropathy

Interventions

DRUG

CBX129801

Sponsors & Collaborators

  • Cebix Incorporated

    lead INDUSTRY

Principal Investigators

  • Dennis Kim, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-11-30
Completion
2015-01-31

Countries

  • United States
  • Canada
  • Sweden

Study Locations

More Related Trials

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 NCT01681290 on ClinicalTrials.gov