Are All Novel Insulins Proven to Be Equally Safe?

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Presentation transcript:

Are All Novel Insulins Proven to Be Equally Safe?

Agenda

Introduction/Background

CV Safety With Intensive Glucose Lowering

Regulatory Request for CV Safety Trials

ORIGIN Trial

DEVOTE: Study Drugs

Rationale for DEVOTE Trial

DEVOTE Baseline Characteristics

DEVOTE: Primary Endpoint Time to First 3-Point MACE

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

DEVOTE Study Design

Hypoglycemia

Less Hypoglycemia With Basal Analogues vs NPH

Treat-to-Target Trial Design

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

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

Glargine U300

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

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

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

Degludec vs Glargine U100: SWITCH Trials Headline Results

DEVOTE Secondary Endpoints: Similar Mean HbA1c Reduction

DEVOTE Secondary Endpoints: Rates of Severe Hypoglycemia

DEVOTE Secondary Endpoints: Rates of Nocturnal Severe Hypoglycemia

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

Hypoglycemia: The Cardiologist’s Perspective

Hypoglycemia: The Endocrinologist’s Perspective

DEVOTE: Trial Design

Conclusions