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
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
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