Clinical trial NCT01293461: Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes
Diabetes Mellitus
Peripheral Diabetic Neuropathy
Lead sponsor: Cebix Incorporated
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Key Inclusion Criteria:

* 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)

Key Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: For duration of study / 16 months
measure: 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.
timeFrame: For duration of study / 16 months
Secondary outcomes:
measure: To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.
timeFrame: Predose and 6 and 12 weeks postdose
measure: To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.
timeFrame: For duration of study / 16 months
measure: To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.
timeFrame: Predose and 6 and 12 weeks postdose
measure: To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)
timeFrame: Predose and 12 weeks postdose
Other outcomes:
Locations:
city: Escondido
country: United States
state: California
city: Tustin
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Butte
country: United States
state: Montana
city: San Antonio
country: United States
state: Texas
city: Olympia
country: United States
state: Washington
city: Renton
country: United States
state: Washington
Study officials:
References: