Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01681290

First Posted: September 7, 2012

Last Update Posted: January 30, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Cebix Incorporated

Tracking Information

First Submitted Date ^ICMJE

September 5, 2012

First Posted Date ^ICMJE

September 7, 2012

Last Update Posted Date

January 30, 2015

Start Date ^ICMJE

October 2012

Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bilateral change in sensory nerve conduction velocity [ Time Frame: Predose and 12 months post dose ]

Original Primary Outcome Measures ^ICMJE

Bilateral change in sensory nerve conduction velocity [ Time Frame: 12 months ]

Change History

Complete list of historical versions of study NCT01681290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Vibration perception threshold [ Time Frame: 12 months ]
Clinical composite score [ Time Frame: 6 and 12 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Peripheral Neuropathy

Intervention ^ICMJE

Drug: CBX129801

Study Arms

Experimental: CBX129801 High Dose
Solution for injection, 2.4 mg, weekly for 52 weeks

Intervention: Drug: CBX129801
Experimental: CBX129801 Low Dose
Solution for injection, 0.8 mg, weekly for 52 weeks

Intervention: Drug: CBX129801
Placebo Comparator: Placebo
Solution for injection, vehicle with no active, weekly for 52 weeks

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

January 2015

Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, Sweden, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01681290

Other Study ID Numbers ^ICMJE

CBX129801-DN-201

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Cebix Incorporated

Study Sponsor ^ICMJE

Cebix Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Investigator:

Dennis Kim, MD

Chief Medical Officer

PRS Account

Cebix Incorporated

Verification Date

January 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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