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A prospective, multi-center, randomized Phase Ib/IIa treatment trial (sequential assignment) to assess the safety and tolerability of different doses of AG019 administered alone vs or AG019 + Teplizumab in patients with clinical recent-onset Type 1 Diabetes Mellitus (T1D)
Primary outcome measures:
Incidence of Treatment-emergent Adverse Events (TEAE
Conclusion:
AG019 as well as AG019 + Teplizumab were well tolerated. AG019 in combination with Teplizumab may have additional biological effects including changes in preproinsulin-specific T-cells. These preliminary data support the continuation of studies with this agent al…