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Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

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. Identifier: NCT01293461
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):
Cebix Incorporated

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Diabetes Mellitus Peripheral Diabetic Neuropathy Drug: CBX129801 Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: CBX129801 Drug: CBX129801
Subcutaneous injection

Placebo Comparator: Placebo Drug: Placebo
Subcutaneous injection

Primary Outcome Measures :
  1. 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.

  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation. [ Time Frame: For duration of study / 16 months ]
  3. 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 ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01293461

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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

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Responsible Party: Cebix Incorporated Identifier: NCT01293461     History of Changes
Other Study ID Numbers: CBX129801-PK-101
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013

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