Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus
1 other identifier
interventional
72
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2011
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 1, 2013
February 1, 2013
1.3 years
February 8, 2011
February 25, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
For duration of study / 16 months
Secondary Outcomes (4)
To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.
Predose and 6 and 12 weeks postdose
To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.
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.
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)
Predose and 12 weeks postdose
Study Arms (2)
CBX129801
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Give informed consent
- Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)
- Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years
- Body mass index of 18-35 kg/m2
- Be C-peptide deficient (assessed by fasting concentration level)
- Normal renal function (assessed by serum creatinine)
- Be in good general health (besides T1DM)
- Have abnormal sural nerve conduction velocity observed bilaterally (Part 2 only)
You may not qualify if:
- Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease
- Unstable glucose control
- Have had a islet cell, kidney, and/or pancreas transplant
- Blood loss or blood donation within 56 days
- Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)
- History or positive test result for Hepatitis B, C, and/or HIV
- Treatment with medication for peripheral neuropathy within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Escondido, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Butte, Montana, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Renton, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2011
First Posted
February 10, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2012
Study Completion
October 1, 2012
Last Updated
March 1, 2013
Record last verified: 2013-02