Protege Encore Study: Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

ClinicalTrials.gov Identifier: NCT00920582

This study is currently recruiting patients recently diagnosed with type 1 diabetes to investigate the efficacy of teplizumab, a drug that may be able to slow the progression of diabetes. This drug, like TolerX’s otelixizumab, binds to a protein called CD3 and prevents it from functioning. This protein occurs in people with and without type 1 diabetes, but it has been implicated as a critical component in disorders where the immune system attacks the body. In the case of type 1 diabetes, the immune system attacks beta cells of the pancreas. This class of drug has so far shown to maintain some insulin secretion in people with newly diagnosed type 1 diabetes, but the effect does not last forever. Nonetheless, it is thought that reducing hyperglycemia early on in the disease progression can have benefits later on. You can read more detail on this drug class in our Learning Curve from diaTribe #15. In this study, patients will be randomized to receive daily injections of either a placebo or teplizumab. There will be two courses of treatment, each lasting two weeks. To be enrolled in this study, subjects must be 8-35 years old, weigh more than 36 kg (79 lb), and have a confirmed diagnosis of type 1 diabetes. To learn more about joining this study, please contact Angela Fields at 301-348-1608 or afields@mmgct.com.