Table 2.

Selected ongoing large-scale, prospective clinical trials

Drug	Study	Estimated enrollment
DPP-IV inhibitors
Alogliptin	Cardiovascular Outcomes Study of Alogliptin in Subjects with Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE): a randomized, double-blind, placebo-control trial to evaluate time to composite CV event following the addition of alogliptin to standard therapy in subjects with T2DM and ACS	5400
Sitagliptin	Sitagliptin Cardiovascular Outcome Study (TECOS): a randomized, placebo-control trial to evaluate the incidence of CV events when sitagliptin is added to standard therapy in patients with T2DM (HbA1Cs 6.5– 8.0%) and CV disease	14,000
Saxagliptin	Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Medications to Other Diabetes Medications (SAVOR-TIMI 53): a randomized, placebo-controlled, phase IV trial to evaluate the incidence of CV events (as well as safety) when saxagliptin is added to standard therapy in patients with T2DM and CV disease	12,000
Saxagliptin	Comparison of Risk of Major Cardiovascular Events Between Patients With Type 2 Diabetes Exposed to Saxagliptin and those Exposed to Other Oral Antidiabetic Treatments: an observational, cohort study to evaluate compare the incidence of major CV events among patients with T2DM who are new users of saxagliptin and those who are new users of other anti-diabetic drugs	180,000
Vildagliptin	Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure: a randomized, placebo-control trial to evaluate the effect (as well as safety and efficacy) of vildagliptin on LV function in patients with T2DM and CHF (NYHA class I–III) by showing that vildagliptin is at least not inferior to placebo with respect to change in LVEF	490
GLP-1 receptor agonists
Taspoglutide	A Study of Taspoglutide in Patient with Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease: a randomized, placebo-controlled trial to assess the time to CV event following the start of taspoglutide and standard therapy (CV and Glycemic) to subjects with uncontrolled T2DM and established CV disease	2000
Exenatide	Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): a randomized, placebo-controlled trial to evaluate time to first confirmed CV event	9500
Liraglutide	Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation (LEADER): a randomized, placebo-controlled trial to assess time to CV event following the addition of liraglutide to standard therapy in subjects with T2DM and CV disease or chronic kidney disease or specific CV risk factors.	8754
Lixasenatide	Evaluation of CV outcomes in Patients with Type 2 Diabetes After Acute Coronary Syndrome During Treatment with AVE0010 (Lixasenatide) (ELIXA)	6000

ACS acute coronary syndrome; CHF congestive heart failure; CV cardiovascular; LVEF left ventricular ejection fraction; NYHA New York Heart Association; T2DM type 2 diabetes mellitus