Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) Trial Results
2:15 p.m.–3:15 p.m. Monday
Halls G-H
Chair: Steven P. Marso, MD
John B. Buse, MD, PhD
DEVOTE is a long-term, multicenter, multinational, randomized, double-blinded, parallel group and event-driven trial conducted to confirm the cardiovascular safety of Tresiba® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people with type 2 diabetes at high risk of cardiovascular disease were randomized to treatment with either Tresiba® or insulin glargine U100 in vial in addition to standard of care.
“The major secondary endpoint focused on severe hypoglycemia. Previously, the ORIGIN trial demonstrated the cardiovascular safety of insulin glargine versus usual care. Prior shorter-duration, open-label studies have suggested that degludec is associated with a lower risk of severe hypoglycemia,” said John B. Buse, MD, PhD, who will discuss the clinical implications of the study.
Presentations and speakers:
- Introduction and Trial Design, Steven P. Marso, MD
- Cardiovascular Outcomes, Darren K. McGuire, MD, MHSc
- Glycemic Efficacy and Hypoglycemia, Bernard Zinman, CM, MD, FRCPC, FACP
- Safety, Richard E. Pratley, MD
- Conclusion and Clinical Implications, John B. Buse, MD, PhD
- Independent Commentary, Elizabeth R. Seaquist, MD
The Integrated Results of the CANVAS Program
3:15 p.m.–4:15 p.m. Monday
Halls G-H
Chair: David R. Matthews, BM, BCh, DPhil
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of adults with type 2 diabetes. Across Phase 3 trials in a broad range of patients, canagliflozin has demonstrated glycemic improvements as well as reductions in body weight and blood pressure.
The CANagliflozin cardioVascular Assessment Study (CANVAS) and CANVAS–Renal (CANVAS-R) trials enrolled more than 10,000 patients with type 2 diabetes and a history or high risk of cardiovascular disease in order to assess the cardiovascular safety and efficacy of canagliflozin. The trials are similar in design and in the enrolled patient population.
The findings of these studies will more clearly define the balance of risks and benefits of canagliflozin, and provide substantial insight into the cardiovascular outcomes of the SGLT2 inhibitor class more broadly. The results of the integrated analysis of CANVAS and CANVAS-R will be reported.
Presentations and speakers:
- Background to the Design of the Trials, Gregory R. Fulcher, MBBS, MD
- Methods for the Trials and the Integrated Analyses, Kenneth W. Mahaffey, BS, MD
- Effects on Cardiovascular Outcomes, Bruce Neal, MB, ChB, PhD
- Effects on Renal Outcomes, Dick de Zeeuw, MD, PhD
- Effects on Safety Outcomes, Vlado Perkovic, MBBS, PhD
- Implications for Clinical Practice, David R. Matthews, BM, BCh, DPhil
- Independent Commentary, Clifford J. Bailey, PhD, FRCP Edin, FRCPath
Type 1 Diabetes Immune Intervention Trials
4:30 p.m.–6:30 p.m. Monday
Ballroom 20A-C
Chair: Chantal Mathieu, MD, PhD
Where are we with disease-modifying therapy in type 1 diabetes?
This session will present results from multiple landmark clinical trials, including the international Diabetes TrialNet’s Oral Insulin Prevention Trial. This double-masked, placebo-controlled study is the largest and longest oral insulin prevention trial ever conducted. Results from TrialNet’s companion study, Immune Effects of Oral Insulin, will also be presented, as well as data from Sweden using GAD vaccine.
The question for all of these studies is whether treatment at early stages of disease can delay progression to clinical (stage 3) type 1 diabetes.
Finally, a fourth trial will report the results of intervention with imatinib (Gleevec) at stage 3 of disease (recent-onset, clinical type 1 diabetes).
Presentations and speakers:
Type 1 Diabetes TrialNet Oral Insulin Trial
- Introduction and Background, Jay S. Skyler, MD, MACP
- Results and Conclusions, Desmond Schatz, MD
- An Oral Insulin Mechanistic Study, Peter A. Gottlieb, MD
- Independent Commentary, David M. Maahs, MD, PhD
Imatinib (Gleevec) in New-Onset Type 1 Diabetes
- Background and Results, Stephen E. Gitelman, MD
DIAPREV-IT Trial with GAD-Vaccine
- Introduction and Background, Åke Lernmark, PhD
- Results and Conclusions, Helena Elding Larsson, MD, PhD
- Independent Commentary, Joseph Wolfsdorf, MB, BCh
