Table 1.

Differences between conventional glycemic trial and CVOTs ¹¹.

	Conventional glycemic efficacy trials	CVOTs
Objective	Efficacy of drug compared with a placebo or comparator	Compare CV outcomes
Number of patients	300–600 (based on sample size calculation)	In thousands
Duration	26–104 weeks	Many years or event driven
Background glycemic therapies	Limited to rescue therapies and dose changes for hypoglycemia	More flexibility for investigator
Comparator	Placebo or active comparator	Usually placebo
Inclusion/exclusion	Mainly low-risk patients or minimal CV risk	Patients with high CV risk factors, known atherosclerotic vascular disease, recent CV event

CVOT: cardiovascular outcome trial; CV:cardiovascular.