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Limitations of use: Not to be used in pregnancy, history of pancreatitis, Type 1 diabetes, personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia type II Warnings & Precautions: Pancreatitis: Has been reported in clinical trials
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Efficacy endpoints were change from baseline in HbA 1c and body weight (and, for the separate PIONEER 8 subgroup analysis, change from baseline in insulin dose) at the planned end of treatment (weeks 26, 52 or 78, according to the trial)
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Strategies to minimize immunogenicity include careful peptide design to maintain similarity to natural sequences, appropriate formulation development, and monitoring for antibody formation during clinical development and post-market surveillance
