Peripheral Neuropathy Trial Now Enrolling

Do you have Type 1 diabetes and peripheral neuropathy? Then you may be interested in the Act1ve Trial, which is currently enrolling participants.

People with Type 1 diabetes lose the ability to produce both insulin and a related substance known as C-peptide. Current Type 1 treatment focus on replacing insulin, but not C-peptide. According to biopharmaceutical manufacturer Cebix, “Published clinical studies suggest that C-peptide is an active hormone in its own right and may be useful in treating complications of type 1 diabetes, particularly loss of sensation (neuropathy).” Cebix has developed a long-acting form of C-peptide (brand name Ersatta) that it will be evaluating in the Act1ve Trial.

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Participants in the trial will receive either weekly injections of Ersatta (approximately 60% of enrollees) or a placebo (inactive treatment; approximately 40% of enrollees) for a year, and researchers will track the effects on a measure of nerve function known as nerve conduction velocity (NCV).

Participants will receive, at no cost, all study-related care, exams and medical testing from the study doctor, the investigational drug, and compensation for time and travel. To qualify for the trial, you must have had Type 1 diabetes for a minimum of five years, have been on a stable diabetes management regimen for at least three months, and be between 18 and 65 years of age. Trial sites in the United States are located in California, Georgia, Idaho, Massachusetts, Michigan, Montana, Nebraska, Nevada, New York, and Texas.

For more information about the trial, including complete eligibility requirements and details on how to enroll, visit the Cebix Web site or see the listing on ClinicalTrials.gov.

This blog entry was written by Web Editor Diane Fennell.

  • Bonnie Lu Brehm

    Your add to apply for the clinical testing is misleading. When one first reads it we are told that if we suffer from Diabetes we should go and see if we qualify, then when we come over to the second page, we are told if you suffer from Diabetes 1 then you qualify.

    This is not a way to run a legitimate business especially when your already making these assumptions at people’s expense.

  • matilde scerri

    I have had diabetes type 2 for the past 10 years and I have very bad neuropathy in hand and feet it is so painful I wonder if you could help me thank you

  • Thom Harrell

    I have Neuropathy in my feet, but I am not a diabetic.
    I would be willing to participate in the trial study.

  • lin

    I have neuropathy in both feet and also have Type 2 diabetes,, Dx. over five years ago.. now on oral meds. Too bad they are not accepting us. I wish interest was shown to Type 2’s, maybe they would not progress to worse symptoms.

  • Brian Gawenus

    i am in Arkansas so there is no trials close to me but I would like more info on medications that can help with neuropathy I have been on insulin pump since 2005 and have had diabetes since 1992 I have it in both hands arms and legs and I have very bad circulation in both legs they are black in color and can develop sores very easy have been to wound care many time if there is any kind of surgery that can be done to help I would love to find out I am so tired of having legs up and wounds to the point I want them cut off, I love to go swimming but with open wounds I can’t it is very disappointing when your kids want to go swimming and dad has to sit out because of the fear of infection let me know please if there is something that can be done

    So depressed and disappointing
    Brian.

  • DJ Rivera

    I have diabetes type 2 and have neuropathy in both my feet. I am taking Mentax for it but it hasn’t helped yet. I have lost 70 lbs and my sugar levels have been good. Is there a trial I can do??

    Thanks so much!

  • Debby Lankrord

    Diabetic 20 yrs type 2 neuropathy really starting up now. not taking anything yet but willing to be a test

  • emily

    I would be honored to participate in the trial study.

    I have type 2 diabetes and have developed stasis dermatitis as a result of pooling blood in my feet, ankles, and legs. No one seems to be able to find or know the cause of this which is very disheartening. The cramping in my limbs come and go at different times, although last week I had to be hospitalized; the cramps occurred in all of my limbs at the same time and I was totally locked. The pain was a pain I’ve never experience before. I’m ready to find someone who can help me.

    Topical medication has worsened the situation because I am 78 years old and my skin is very thin and sensitive. I’m fighting depression daily because all of the doctors have told me I must learn to live with this because doctors don’t know what causes it. Is this true?

    My diabetes educator is no longer at the hospital where she was employed and I have no way to locate her.

    There is no doubt that I need help; perhaps the trial study would help not only me, but others like me.

  • Jody Williams

    I have type 2 diabetes, but have had it almost 25 years and have developed pretty bad neuropathy in my feet….really worrying me….can I be a part of this study too?? Please?

    Jody Williams

  • Johnna Ritchey

    I have type one diabetes and I’m very interested in this study that is being done. Please send me information to my e-mail address on the study. I would be happy to participate in this. Thank you.

  • Kelli Plunkett

    I have had type 2 diabetes for 12 years. Have been insulin dependent for 6 years. I recently had to have a toe removed (June 25, 2013) due to a blister getting infected and the infection went into the bone. All of this happened because I have neuropathy very bad in my feet.

  • Russell Stratton

    I have type 2 diabetes as well as diabetic neuropathy. I have had this for 15 years. My glucose is under control thru diet and exercise. I am 77 years old and other than the diabetes I am in good health. Because of the diabetic neuropathy my balance is bad as is the pain in my legs. I take Gabapentin for the neuropathy. I would love to be part of a trial. Is there any chance or does everyone write off the older senior citizens.

  • Diane Fennell

    Hi everyone,

    Thanks for your comments. For complete information on the Act1ve Trial, please click here.

    For those of you who have Type 2 diabetes and are interested in participating in a neuropathy trial, you can search on ClinicalTrials.gov for studies that are currently recruiting. A search done on “Type 2 diabetes, neuropathy” on August 1, 2013, brings up these results.

    Best,
    Diane Fennell
    Web Editor

  • vie

    I have had Diabetes for 21 years. WHY did the article in beging of the article stat TYPE 1 need only read?
    Waste of my “hopes and time”

  • susan palmer

    Why only for Type 1 diabetics?

  • Robert Link

    I have had type 2 for at least 10 years I suffer from severe neuropathy in my feet for many of those years with very little releaf even when my numbers are right on. I recently had to quit my job because I had no feeling in my feet and could not climb on and off equipment and walking on snow and ice was a real choreI would like to try this trial

  • Ludovico Croati

    For those who have cramps very often in their extremities should take 25o/3OO mg of Magnesium
    daily.It helps me a lot.Lud.Croati

  • carl

    I have heard that cinnamon and chromium picolinate will help diabetics.

    Does anyone know about this?

    I have no idea as to how much to take or use on a daily basis. I am going to ask my Dr. about this.

  • emily hubbard

    I have taken 50 mg of potassium once a day since being diagnosed with Type 2 diabetes and statis dermatitis to stop the horrible cramping in my hands, fingers, feet, toes, legs, hips, arms, etc. I am reading about the magnesium and will try that as well, although I am one of those who is just as afraid of taking too much as well as taking too little. HELP!