A Study to Evaluate Ersatta™ (Long-Acting C-peptide) in Type 1 Diabetes Mellitus Patients with Diabetic Peripheral Neuropathy
- Conditions
- Mild to moderate diabetic peripheral neuropathyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-001246-17-SE
- Lead Sponsor
- Cebix Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
Give informed consent;
18 - 65 years old;
Have type 1 diabetes mellitus for a minimum of 5 years (or 4 years with Investigator and Sponsor documented approval, based on patient’s presentation at screening), with a stable diabetic regimen (for at least 3 months) that provides adequate glucose control;
Have clinical signs of diabetic peripheral neuropathy at screening;
Have abnormal sural nerve conduction bilaterally during screening;
Be C-peptide deficient;
Be in good general health (besides having type 1 diabetes mellitus);
Practice effective contraception during the study and for 12 weeks after study participation;
Have a body mass index (BMI) =18.0 and <35.0 kg/m2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;
Any condition that could mimic diabetic peripheral neuropathy or impair peripheral nerve function;
Known or suspected hypersensitivity or allergic reaction to C-peptide or any of the excipients in CBX129801;
Have unstable or inadequate glucose control;
Any significant clinical laboratory value at screening;
Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of the first dose of study drug, 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, or human immunodeficiency virus (HIV);
Initiation of treatment or change of dose of medications 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 within 60 days.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of subcutaneously administered CBX129801 in type 1 diabetes mellitus subjects with mild to moderate diabetic peripheral neuropathy.;Secondary Objective: To assess the efficacy of CBX129801 by evaluating neurophysiological changes over time, the clinical value of CBX129801 therapy, the safety and tolerability of CBX129801, the population pharmacokinetic profile of CBX129801, and the immunogenicity of CBX129801.<br>;Primary end point(s): Bilateral change from baseline to 52 weeks in initial sensory nerve conduction velocity (SNCVi) in the sural nerve;Timepoint(s) of evaluation of this end point: SNCVi baseline assessed during screening prior to initial dose and at Week 52 (or at early termination)
- Secondary Outcome Measures
Name Time Method