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Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

This study is currently recruiting participants.
Verified November 2012 by Cebix Incorporated
Sponsor:
Information provided by (Responsible Party):
Cebix Incorporated
ClinicalTrials.gov Identifier:
NCT01681290
First received: September 5, 2012
Last updated: February 27, 2013
Last verified: November 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 240
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681290

Contacts
Contact: Lina Willis 858-729-6501 clinicaltrials@cebix.com

  Show 28 Study Locations
Sponsors and Collaborators
Cebix Incorporated
  More Information

No publications provided

Responsible Party: Cebix Incorporated
ClinicalTrials.gov Identifier: NCT01681290     History of Changes
Other Study ID Numbers: CBX129801-DN-201
Study First Received: September 5, 2012
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on May 19, 2013