A study of Diamyd demonstrated safety and efficacy in slowing the decline of C-peptide levels at 15 months. Diamyd patients also required less insulin than placebo and patients with a disease duration shorter than three months showed an improved insulin production.
The results from the study demonstrated that the group of 35 recently diagnosed type 1 diabetes patients that received Diamyd produced approximately twice as much meal-stimulated insulin, as measured by C-peptide levels 15 months after the first treatment, as the placebo group.
As insulin and C-peptide are produced in equal amounts and C-peptide is easier to measure, meal-stimulated C-peptide levels is the most important parameter to follow in a type 1-diabetes study where the aim is to preserve beta cell function. C-peptide levels in both groups experienced a decline but the decline was significantly inhibited in the Diamyd group.
These results provide strong support that the administration of Diamyd is effective in preserving islet cell function in type 1-diabetes patients. Additionally, maintenance of endogenous insulin production is important as it helps patients to better control their disease and reduce long-term complications.
There were no serious adverse events reported that were related to the Diamyd treatment.
“With these positive results in the type 1 diabetes study, the likelihood that the ongoing phase II clinical trial with 160 latent autoimmune diabetes in adults (LADA) patients will be successful has increased,” said Anders Essen-Moller, president and CEO of Diamyd Medical.
The study is now in a follow-up stage of 15 months. Preliminary results from the LADA trial are planned to be presented in the summer 2007.