Patients who are newly diagnosed with type 1 diabetes that take two courses of alefacept display preserved beta cell function after two years.
The Phase II study, published in the Journal of Clinical Investigatio, was led by Mark Rigby, MD, PhD, Indiana University.
Rigby’s team recruited 49 patients with new-onset type 1 diabetes between the ages of 12 and 35. The participants either received alefacept – an engineered fusion protein – or placebo.
The alefacept group received two 12-week courses of treatment. After 24 months, or 15 months following the last dose of alefacept, the participants displayed significantly lower C-peptide production decline, indicating preservation of beta cell function.
Lower insulin requirements and fewer hypoglycemic events were also reported compared to the placebo group, with no serious adverse effects associated with alefacept.
Mario Ehlers, MD, PhD, who worked on the study, said: “The two-year results are remarkable because we observed ongoing preservation of C-peptide secretion 15 months after cessation of treatment.
“This is the first time that documented rates of hypoglycemia – using standardized home glucometers in all patients – have shown a reduction in major hypoglycemic events following an immune intervention in new-onset T1D patients. This is important because frequent hypoglycemia is a common and serious complication in this disease.”
Preserving even a small level of insulin production can have benefits for people with type 1 diabetes, such as reduced hypoglycemia and improved glycemic control.
Future studies will now aim to combine alefacept with other therapeutic agents to create a metabolic response that lasts even longer in type 1 patients.

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