1. Are All Novel Insulins Proven to Be Equally Safe?

3. Agenda

4. Introduction/Background

5. CV Safety With Intensive Glucose Lowering

6. Regulatory Request for CV Safety Trials

7. ORIGIN Trial

8. DEVOTE: Study Drugs

9. Rationale for DEVOTE Trial

10. DEVOTE Baseline Characteristics

11. DEVOTE: Primary Endpoint Time to First 3-Point MACE

12. DEVOTE Primary Endpoints: 3-Point MACE, 4-Point MACE, and All-Cause Death

13. DEVOTE Study Design

14. Hypoglycemia

15. Less Hypoglycemia With Basal Analogues vs NPH

16. Treat-to-Target Trial Design

17. EDITION T2DM Trials Meta-Analysis: Glargine U300 vs Glargine U100

18. EDITION T2DM Trials Meta-Analysis: Lower Confirmed/Severe and Nocturnal Hypoglycemia With Glargine U300 vs U100

19. Glargine U300

20. Degludec vs Glargine U100: BEGIN Trials Meta-Analysis of Patients With T2DM on High Doses of Insulin

21. Hypoglycemia Rates With Novel Basal Analogues Meta-Analysis: Insulin Degludec vs Glargine

22. Degludec vs Glargine U100: SWITCH Trials Crossover Study Design in Patients With T1DM and T2DM

23. Degludec vs Glargine U100: SWITCH Trials Headline Results

24. DEVOTE Secondary Endpoints: Similar Mean HbA1c Reduction

25. DEVOTE Secondary Endpoints: Rates of Severe Hypoglycemia

26. DEVOTE Secondary Endpoints: Rates of Nocturnal Severe Hypoglycemia

27. DEVOTE: EAC-Confirmed Severe Hypoglycemia in This Double-Blinded Trial

28. Hypoglycemia: The Cardiologist’s Perspective

29. Hypoglycemia: The Endocrinologist’s Perspective

30. DEVOTE: Trial Design

31. Conclusions