Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 1 Diabetes Diabetes Mellitus Peripheral Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CBX129801

Group Type EXPERIMENTAL

CBX129801

Intervention Type DRUG

Subcutaneous injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection

Interventions

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CBX129801

Subcutaneous injection

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No