Act1ve Study: Safety and Efficacy of Ersatta for Diabetic Peripheral Neuropathy in Patients with Type 1 Diabetes

Article in diaTribe Identifier: NCT01681290

Are you worried about someday getting neuropathy? Do you have it now? Do you suspect you may have it and not know? One common complication of type 1 diabetes is diabetic peripheral neuropathy (DPN), which 60-70% of people with diabetes eventually develop. DPN is the loss of nerve function, and leads to the gradual loss of sensation in the limbs. Early symptoms are so subtle that most don’t realize there is a problem until they experience numbness, tingling, loss of touch, and chronic pain in the hands and feet. By this time, the DPN can be fairly severe and can lead to serious complications. Healthcare providers can determine if someone has DPN by measuring changes in the speed of electrical signals in nerves, which is called the nerve conduction velocity (NCV).

Cebix is developing Ersatta, a drug that could slow or prevent the progression of DPN. It is one of the few drugs being developed that treats a diabetes complication directly rather than preventing it through blood glucose management. Ersatta contains a long-acting form of C-peptide, which has been shown in pre-clinical studies to improve the conduction of nerve signaling. C-peptide is a molecule that is made during the process of making insulin, and because patients with type 1 diabetes do not make insulin, they also do not make C-peptide. Some researchers believe that the molecule plays a role in maintaining microvascular blood circulation and the health of nerves.

Before participants are enrolled into the study, they are screened for DPN by using a test that measures their NCV. Even if they do not experience any symptoms of numbness, volunteers can still get screened for the study and have their nerve health evaluated. If mild to moderate DPN is found, participants are enrolled and receive either once-weekly injections of Ersatta (60% of participants) or a placebo (40% of participants). The study lasts for about one year. In order to enroll in the study, participants must be 18-65 years old, have had type 1 diabetes for at least five years, and be C-peptide deficient. During the year, participants will need to travel to study centers 12 times and are compensated for their time and travel. There are trial centers in CA, GA, ID, MA, MI, MT, NB, NV, NY, and TX in the United States, AB, ON, QC in Canada, and locations in Sweden as well. If you are interested in participating in the study please visit,, or -MN

I am participating in this clinical trial right now.

This survey post has been approved by the TuDiabetes Admin Team.

I didn't know this was a survey ?

i went through the survey to see if I qualified, and RA kept me from qualifying. Well I tried, I wanted to go to Ann Arbor once a month and see my grand children at the studies expense. LOL


I also am currently participating in this study. I'm excited to hear the outcome!T1D 52 years.

Glad to know I'm not the only one here participating. I just took my second dose of study medication on Monday. So far so good. T1D 38 years for me.

Yes, I've always wanted to do some sort of research related help. I just did my 4th injection. I think they wait until 26 weeks to take blood to see if any results. Anyway, glad to meet you!

They take blood often, but that is not what gives them the results it bascially looks at liver chemistry, kidney stuff and other parameters which the original test subjects showed some change. It is the NCV testing and the vibration testing that gives them the results. The NCV testing is done as a pre-screen, then at week 26 and at week 52. And both of those visits also include a fasting blood draw. And both times the NCV and VPT tests need to be repeated within 14 days.
I'm sure they gave you the whole consent form. But it outlines the visits at weeks 4, 8, 16, 26, 39 and 52 and all of them involve a blood draw. Most involve a urine sample presumably to look at kidney stuff.

So far I have noticed a big increase in hypos in fact yesterday I spent 26% of the day below 70 mg/dl. I have had to dial back the basal and bolus on the pod and even then it's not enough to stop the lows. Trying to keep in control is going to be a challenge at least until I figure out what the drug is doing but I am only on dose 2 so it is hard to tell.

Glad to meet you as well !