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Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01681290
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : January 30, 2015
Information provided by (Responsible Party):
Cebix Incorporated

Brief 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).

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Drug: CBX129801 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bilateral change in sensory nerve conduction velocity [ Time Frame: Predose and 12 months post dose ]

Secondary Outcome Measures :
  1. Vibration perception threshold [ Time Frame: Predose and 6 and 12 months post dose ]
  2. Clinical composite score [ Time Frame: Predose and 6 and 12 months post dose ]
  3. Pain Intensity due to DPN [ Time Frame: Predose and 12 months post dose ]
  4. Sexual function questionnaires [ Time Frame: Predose and 6 and 12 months post dose ]
  5. Quality of life questionnaire [ Time Frame: Predose and 12 months post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681290

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United States, California
Escondido, California, United States, 92026
Fresno, California, United States, 93720
Irvine, California, United States, 92618
Los Angeles, California, United States, 90036
San Diego, California, United States, 92161
San Francisco, California, United States, 94110
Torrance, California, United States, 90502
Tustin, California, United States, 92780
Walnut Creek, California, United States, 94598
United States, Georgia
Atlanta, Georgia, United States, 30318
Decatur, Georgia, United States, 30033
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Montana
Butte, Montana, United States, 59701
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New York
New York, New York, United States, 10032
United States, Texas
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77030
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78229
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Laval, Quebec, Canada, H7T 2P5
Göteborg, Sweden, 413 45
Linköping, Sweden, 581 85
Malmo, Sweden, 20502
Stockholm, Sweden, 171 76
Umea, Sweden, 90185
Sponsors and Collaborators
Cebix Incorporated
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OverallOfficial: Dennis Kim, MD Chief Medical Officer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cebix Incorporated
ClinicalTrials.gov Identifier: NCT01681290    
Other Study ID Numbers: CBX129801-DN-201
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications