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Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Cebix Incorporated Identifier:
First received: September 5, 2012
Last updated: January 28, 2015
Last verified: January 2015
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).

Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: CBX129801
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Cebix Incorporated:

Primary Outcome Measures:
  • Bilateral change in sensory nerve conduction velocity [ Time Frame: Predose and 12 months post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vibration perception threshold [ Time Frame: Predose and 6 and 12 months post dose ] [ Designated as safety issue: No ]
  • Clinical composite score [ Time Frame: Predose and 6 and 12 months post dose ] [ Designated as safety issue: Yes ]
  • Pain Intensity due to DPN [ Time Frame: Predose and 12 months post dose ] [ Designated as safety issue: No ]
  • Sexual function questionnaires [ Time Frame: Predose and 6 and 12 months post dose ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: Predose and 12 months post dose ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: October 2012
Study Completion Date: January 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBX129801 High Dose
Solution for injection, 2.4 mg, weekly for 52 weeks
Drug: CBX129801
Experimental: CBX129801 Low Dose
Solution for injection, 0.8 mg, weekly for 52 weeks
Drug: CBX129801
Placebo Comparator: Placebo
Solution for injection, vehicle with no active, weekly for 52 weeks


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Give informed consent;
  • 18-65 years old;
  • Have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen (for at least 3 months);
  • Have clinical signs of diabetic peripheral neuropathy at screening;
  • Have abnormal sural nerve conduction observed bilaterally during screening;
  • Be C-peptide deficient;
  • Be in good general health (besides having type 1 diabetes mellitus);
  • Practice effective contraception during and for at least 12 weeks after study participation;
  • Have a body mass index (BMI) ≥18.0 and <35.0 kg/m2.

Key Exclusion Criteria:

  • Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;
  • Unstable or inadequate glucose control;
  • Any clinically significant laboratory value at screening;
  • Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of Day 0, or recurrent episodes of non-severe hypoglycemia (≥3 per week on average) that are deemed clinically significant by the Investigator;
  • Have had an islet cell, kidney, and/or pancreas transplant;
  • If female, is pregnant or lactating;
  • History of alcohol or substance abuse within 2 years;
  • Positive screen for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;
  • Initiation of treatment or change of dose of medication that could affect peripheral nerve function within 60 days;
  • Previous treatment with CBX129801 or unmodified C-peptide;
  • Receipt of an investigational product or therapeutic device, or participation in a drug research study, within a period of 30 days;
  • Chronic use of oral steroids or use of Ampyra (dalfampridine) within 60 days.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01681290

  Show 29 Study Locations
Sponsors and Collaborators
Cebix Incorporated
OverallOfficial: Dennis Kim, MD Chief Medical Officer
  More Information

Responsible Party: Cebix Incorporated Identifier: NCT01681290     History of Changes
Other Study ID Numbers: CBX129801-DN-201 
Study First Received: September 5, 2012
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases processed this record on May 26, 2016