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Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293461
First Posted: February 10, 2011
Last Update Posted: March 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cebix Incorporated
February 8, 2011
February 10, 2011
March 1, 2013
April 2011
August 2012   (Final data collection date for primary outcome 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. [ Time Frame: For duration of study / 16 months ]
    Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
  • 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 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. [ Time Frame: For duration of study / 12 months ]
    Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
  • 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 / 12 months ]
Complete list of historical versions of study NCT01293461 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 / 12 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 ]
Not Provided
Not Provided
 
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
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Diabetes Mellitus
  • Peripheral Diabetic Neuropathy
  • Drug: CBX129801
    Subcutaneous injection
  • Drug: Placebo
    Subcutaneous injection
  • Experimental: CBX129801
    Intervention: Drug: CBX129801
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01293461
CBX129801-PK-101
No
Not Provided
Not Provided
Cebix Incorporated
Cebix Incorporated
Not Provided
Not Provided
Cebix Incorporated
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP