Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

Tracking Information
First Submitted Date ICMJE	September 5, 2012
First Posted Date ICMJE	September 7, 2012
Last Update Posted Date	January 30, 2015
Study Start Date ICMJE	October 2012
Actual Primary Completion Date	November 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 6, 2012)	Bilateral change in sensory nerve conduction velocity [ Time Frame: Predose and 12 months post dose ]
Original Primary Outcome Measures ICMJE; (submitted: September 5, 2012)	Bilateral change in sensory nerve conduction velocity [ Time Frame: 12 months ]
Change History	Complete list of historical versions of study NCT01681290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 12, 2013)	Vibration perception threshold [ Time Frame: Predose and 6 and 12 months post dose ]; Clinical composite score [ Time Frame: Predose and 6 and 12 months post dose ]; Pain Intensity due to DPN [ Time Frame: Predose and 12 months post dose ]; Sexual function questionnaires [ Time Frame: Predose and 6 and 12 months post dose ]; Quality of life questionnaire [ Time Frame: Predose and 12 months post dose ]
Original Secondary Outcome Measures ICMJE; (submitted: September 5, 2012)	Vibration perception threshold [ Time Frame: 12 months ]; Clinical composite score [ Time Frame: 6 and 12 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
Official Title ICMJE	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
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).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Diabetic Peripheral Neuropathy
Intervention ICMJE	Drug: CBX129801
Study Arms	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
Publications *	Wahren J, Foyt H, Daniels M, Arezzo JC. Long-Acting C-Peptide and Neuropathy in Type 1 Diabetes: A 12-Month Clinical Trial. Diabetes Care. 2016 Apr;39(4):596-602. doi: 10.2337/dc15-2068. Epub 2016 Feb 16.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 28, 2015)	250
Original Estimated Enrollment ICMJE; (submitted: September 5, 2012)	240
Actual Study Completion Date	January 2015
Actual Primary Completion Date	November 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, Sweden, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01681290
Other Study ID Numbers ICMJE	CBX129801-DN-201
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Cebix Incorporated
Study Sponsor ICMJE	Cebix Incorporated
Collaborators ICMJE	Not Provided
Investigators ICMJE	Investigator: Dennis Kim, MD Chief Medical Officer
PRS Account	Cebix Incorporated
Verification Date	January 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP