Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293461
• Other study ID #: CBX129801-PK-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 8, 2011
• Last updated: February 25, 2013
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Cebix Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Neuropathies
• Peripheral Diabetic Neuropathy
• Type 1 Diabetes

Intervention

Drug:
• CBX129801
Subcutaneous injection
• Placebo
Subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cebix Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.	For duration of study / 16 months	No
Primary	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.		For duration of study / 16 months	Yes
Secondary	To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.		Predose and 6 and 12 weeks postdose	No
Secondary	To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.		For duration of study / 16 months	Yes
Secondary	To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.		Predose and 6 and 12 weeks postdose	No
Secondary	To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)		Predose and 12 weeks postdose	No