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Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cebix Incorporated
ClinicalTrials.gov Identifier:
NCT01681290
First received: September 5, 2012
Last updated: January 28, 2015
Last verified: January 2015
History of Changes

September 5, 2012
January 28, 2015
October 2012
November 2014   (final data collection date for primary outcome measure)
Bilateral change in sensory nerve conduction velocity [ Time Frame: Predose and 12 months post dose ] [ Designated as safety issue: No ]
Bilateral change in sensory nerve conduction velocity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01681290 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Vibration perception threshold [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical composite score [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Peripheral Neuropathy
Drug: CBX129801
  • Experimental: CBX129801 High Dose
    Solution for injection, 2.4 mg, weekly for 52 weeks
    Intervention: Drug: CBX129801
  • Experimental: CBX129801 Low Dose
    Solution for injection, 0.8 mg, weekly for 52 weeks
    Intervention: Drug: CBX129801
  • Placebo Comparator: Placebo
    Solution for injection, vehicle with no active, weekly for 52 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
January 2015
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Sweden
 
NCT01681290
CBX129801-DN-201
No
Not Provided
Not Provided
Cebix Incorporated
Cebix Incorporated
Not Provided
Investigator: Dennis Kim, MD Chief Medical Officer
Cebix Incorporated
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP