All the patients had established cardiovascular disease (as defined in Section C in the Supplementary Appendix) and had received no glucose-lowering agents for at least 12 weeks before randomization and had a glycated hemoglobin level of at least 7.0% and no more than 9.0% or had received stable glucose-lowering therapy for at least 12 weeks before randomization and had a glycated hemoglobin level of at least 7.0% and no more than 10.0%. Other key exclusion criteria are provided in Section D in the Supplementary Appendix.