ClinicalTrials.gov 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 www.diabetesnervestudy.com, www.ClinicalTrials.gov, or www.cebix.com. -MN