NCT01681290

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
3 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

September 5, 2012

Last Update Submit

January 28, 2015

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Bilateral change in sensory nerve conduction velocity

    Predose and 12 months post dose

Secondary Outcomes (5)

  • 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

Study Arms (3)

CBX129801 High Dose

EXPERIMENTAL

Solution for injection, 2.4 mg, weekly for 52 weeks

Drug: CBX129801

CBX129801 Low Dose

EXPERIMENTAL

Solution for injection, 0.8 mg, weekly for 52 weeks

Drug: CBX129801

Placebo

PLACEBO COMPARATOR

Solution for injection, vehicle with no active, weekly for 52 weeks

Interventions

CBX129801DRUG
CBX129801 High DoseCBX129801 Low Dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Give informed consent;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Unknown Facility

Escondido, California, 92026, United States

Location

Unknown Facility

Fresno, California, 93720, United States

Location

Unknown Facility

Irvine, California, 92618, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

San Diego, California, 92161, United States

Location

Unknown Facility

San Francisco, California, 94110, United States

Location

Unknown Facility

Torrance, California, 90502, United States

Location

Unknown Facility

Tustin, California, 92780, United States

Location

Unknown Facility

Walnut Creek, California, 94598, United States

Location

Unknown Facility

Atlanta, Georgia, 30318, United States

Location

Unknown Facility

Decatur, Georgia, 30033, United States

Location

Unknown Facility

Idaho Falls, Idaho, 83404, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Butte, Montana, 59701, United States

Location

Unknown Facility

Omaha, Nebraska, 68131, United States

Location

Unknown Facility

Las Vegas, Nevada, 89102, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Toronto, Ontario, M5G 2C4, Canada

Location

Unknown Facility

Laval, Quebec, H7T 2P5, Canada

Location

Unknown Facility

Gothenburg, 413 45, Sweden

Location

Unknown Facility

Linköping, 581 85, Sweden

Location

Unknown Facility

Malmo, 20502, Sweden

Location

Unknown Facility

Stockholm, 171 76, Sweden

Location

Unknown Facility

Umeå, 90185, Sweden

Location

Related Publications (1)

  • Wahren J, Foyt H, Daniels M, Arezzo JC. Long-Acting C-Peptide and Neuropathy in Type 1 Diabetes: A 12-Month Clinical Trial. Diabetes Care. 2016 Apr;39(4):596-602. doi: 10.2337/dc15-2068. Epub 2016 Feb 16.

    PMID: 26884473DERIVED

MeSH Terms

Interventions

CBX129801

Study Officials

  • Dennis Kim, MD

    Chief Medical Officer

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 7, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

CA(2)US(22)SE(5)