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.
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.
This blog entry was written by Web Editor Diane Fennell.