Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cebix Incorporated
ClinicalTrials.gov Identifier:
NCT01293461
First received: February 8, 2011
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Diabetes Mellitus
Peripheral Diabetic Neuropathy
Drug: CBX129801
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cebix Incorporated:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation. [ Time Frame: For duration of study / 16 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBX129801 Drug: CBX129801
Subcutaneous injection
Placebo Comparator: Placebo Drug: Placebo
Subcutaneous injection

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293461

Locations
United States, California
Escondido, California, United States
Tustin, California, United States
Walnut Creek, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Montana
Butte, Montana, United States
United States, Texas
San Antonio, Texas, United States
United States, Washington
Olympia, Washington, United States
Renton, Washington, United States
Sponsors and Collaborators
Cebix Incorporated
  More Information

No publications provided

Responsible Party: Cebix Incorporated
ClinicalTrials.gov Identifier: NCT01293461     History of Changes
Other Study ID Numbers: CBX129801-PK-101
Study First Received: February 8, 2011
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on July 09, 2014