Trial | NCT01293461  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    c-peptide ...

  • Study Participants

    72
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.
Study Started
Apr 30
2011
Primary Completion
Aug 31
2012
Study Completion
Oct 31
2012
Last Update
Mar 01
2013
Estimate

Drug CBX129801

Subcutaneous injection

Drug Placebo

Subcutaneous injection

CBX129801 Experimental

Placebo Placebo Comparator

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
No Results Posted