Emerging CVOT Data and Clinical Application

9 Years Since the FDA’s 2008 Guidance on CVOTs for T2D Drugs

3 DPP-4 Inhibitors and 1 GLP-1 RA Were the First to Demonstrate CV Safety

Now 4 CVOTs Demonstrate CV Benefit

ORIGIN CVOT of Insulin Glargine

DEVOTE CVOT of Insulin Degludec

CANVAS Program Included CANVAS and CANVAS-R

Canagliflozin Lowered Risk for CV Death, Nonfatal MI, and Nonfatal Stroke

Is Canagliflozin Renoprotective?

EMPA-REG OUTCOME and CANVAS

Baseline Characteristics of Population in EMPA-REG OUTCOME

CANVAS Primary Prevention and Secondary Prevention and Effect on Stroke

EMPA-REG OUTCOME and CANVAS Heart Failure Hospitalization and Death From CV Causes

Putting Data Into Clinical Context

CVOTs Designed for Glycemic Equipoise

Exploring the Potential Renal Benefits of Canagliflozin

Ongoing Renal Outcome Studies

Higher Risk for Amputations in Patients Taking Canagliflozin

FDA Safety Alert May 16, 2017

Fracture Risk for Canagliflozin in CANVAS

Closing Comments

Abbreviations

Abbreviations (cont)