Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01681290

Enrollment

250

Registered

2012-09-07

Start date

2012-10-31

Completion date

2015-01-31

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Brief 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).

Interventions

DRUGCBX129801

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Bilateral change in sensory nerve conduction velocity	Predose and 12 months post dose

Secondary

Measure	Time frame
Vibration perception threshold	Predose and 6 and 12 months post dose
Clinical composite score	Predose and 6 and 12 months post dose
Pain Intensity due to DPN	Predose and 12 months post dose
Sexual function questionnaires	Predose and 6 and 12 months post dose
Quality of life questionnaire	Predose and 12 months post dose

Countries

Canada, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026