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In the prespecified pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the overall incidence of adverse reactions of hypoglycemia in patients treated with Januvia 100 mg was similar to placebo (1.2% vs 0.9%)

No.S1420087 CAS

Information from clinicaltrials.gov

4 Variability, dose criticality, and regulatory infeasibility Beyond pharmacokinetic infeasibility rooted in accumulation failure, oral peptide and protein development encounters a second, distinct barrier at the regulatory interface: the inability to demonstrate reproducible exposure and bioequivalence