Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Drug: CBX129801

• Registration Number: NCT01681290
• Lead Sponsor: Cebix Incorporated

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-07
• Study Start: 2012-10
• Primary Completion: 2014-11
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBX129801 High Dose	CBX129801	Solution for injection, 2.4 mg, weekly for 52 weeks
CBX129801 Low Dose	CBX129801	Solution for injection, 0.8 mg, weekly for 52 weeks

Primary Outcome Measures

Name	Time	Method
Bilateral change in sensory nerve conduction velocity	Predose and 12 months post dose

Secondary Outcome Measures

Name	Time	Method
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
Vibration perception threshold	Predose and 6 and 12 months post dose