A Phase 1/2 interventional study of CBX129801 and Placebo in Type 1 Diabetes, Diabetes Mellitus and Peripheral Diabetic Neuropathy, sponsored by Cebix Incorporated. Completed at 8 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-03-01.
Sponsored by Cebix Incorporated · Phase 1/2, Interventional, and Treatment
The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.
This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2 of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological C-peptide levels in healthy, non-diabetic individuals.
617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.
This study's enrollment of 72 is close to the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Cebix Incorporated is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: CBX129801
Drug: Placebo
Subcutaneous injection
Subcutaneous injection
To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life.
Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
Time frame: For duration of study / 16 months
To assess the safety and tolerability of CBX129801 when administered SC by adverse events, injection site assessments, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms.
Time frame: For duration of study / 16 months
To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.
Time frame: Predose and 6 and 12 weeks postdose
To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.
Time frame: For duration of study / 16 months
To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.
Time frame: Predose and 6 and 12 weeks postdose
To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)
Time frame: Predose and 12 weeks postdose
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Cebix Incorporated