Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681290
• Other study ID #: CBX129801-DN-201
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2012
• Last updated: January 28, 2015
• Start date: October 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• 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 the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• Give informed consent;

• 18-65 years old;

• Have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen (for at least 3 months);

• Have clinical signs of diabetic peripheral neuropathy at screening;

• Have abnormal sural nerve conduction observed bilaterally during screening;

• Be C-peptide deficient;

• Be in good general health (besides having type 1 diabetes mellitus);

• Practice effective contraception during and for at least 12 weeks after study participation;

• Have a body mass index (BMI) =18.0 and <35.0 kg/m2.

Key Exclusion Criteria:

• Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;

• Unstable or inadequate glucose control;

• Any clinically significant laboratory value at screening;

• Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of Day 0, or recurrent episodes of non-severe hypoglycemia (=3 per week on average) that are deemed clinically significant by the Investigator;

• Have had an islet cell, kidney, and/or pancreas transplant;

• If female, is pregnant or lactating;

• History of alcohol or substance abuse within 2 years;

• Positive screen for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;

• Initiation of treatment or change of dose of medication that could affect peripheral nerve function within 60 days;

• Previous treatment with CBX129801 or unmodified C-peptide;

• Receipt of an investigational product or therapeutic device, or participation in a drug research study, within a period of 30 days;

• Chronic use of oral steroids or use of Ampyra (dalfampridine) within 60 days.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• CBX129801

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cebix Incorporated

Countries where clinical trial is conducted

United States,  Canada,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilateral change in sensory nerve conduction velocity		Predose and 12 months post dose	No
Secondary	Vibration perception threshold		Predose and 6 and 12 months post dose	No
Secondary	Clinical composite score		Predose and 6 and 12 months post dose	Yes
Secondary	Pain Intensity due to DPN		Predose and 12 months post dose	No
Secondary	Sexual function questionnaires		Predose and 6 and 12 months post dose	No
Secondary	Quality of life questionnaire		Predose and 12 months post dose	No