Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT01681290 |
Recruitment Status
:
Completed
First Posted
: September 7, 2012
Last Update Posted
: January 30, 2015
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Sponsor:
Cebix Incorporated
Information provided by (Responsible Party):
Cebix Incorporated
Tracking Information | ||||
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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 |
Bilateral change in sensory nerve conduction velocity [ Time Frame: Predose and 12 months post dose ] | |||
Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Diabetic Peripheral Neuropathy | |||
Intervention ICMJE | Drug: CBX129801 | |||
Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
250 | |||
Original Estimated Enrollment ICMJE |
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:
Key Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (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 |
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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 |