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They declined

Although its exact cause might be unknown in several instances, numerous identifiable factors play a role in onset of the condition

A Add a second oral agent (such as a sulfonylurea, thiazolidinedione, sodium-glucose cotransporter-2 inhibitor, or dipeptidyl peptidase 4 inhibitor), a glucagon-like peptide-1 (GLP-1) receptor agonist, or basal insulin if metformin at a maximum tolerated dose does not achieve the HbA1c target over 3 months

Because of the increased requirements applicable to these types of studies, it is critical that companies conducting these studies carefully structure their drug development programs to ensure that all studies are appropriately capturing the level of detail and thoroughness which FDA will require when reviewing an NDA

Placebo was provided as normal saline, the volume matching the investigational drug at each dose level