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In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
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Cardiovascular Outcomes Trials Update: Insights from the DEVOTE Trial.
Anika Bilal1, Richard E Pratley2,3
1Florida Hospital Translational Research Institute for Metabolism and Diabetes, 301 East Princeton Street, Orlando, FL, 32804, USA.
Current Diabetes Reports
|September 20, 2018
Summary
The DEVOTE study found degludec insulin to be as safe for cardiovascular events as insulin glargine U100 in type 2 diabetes patients. Degludec showed significantly lower rates of severe hypoglycemia, suggesting it may be a preferred option for high-risk individuals.
Area of Science:
- Cardiovascular safety of diabetes medications
- Endocrinology and metabolism
- Clinical trial research
Background:
- Type 2 diabetes (T2D) patients often have high cardiovascular disease (CVD) risk.
- Basal insulins are crucial for glycemic control but require safety evaluation in high-risk populations.
- The DEVOTE trial specifically addressed the cardiovascular safety of degludec versus insulin glargine U100.
Purpose of the Study:
- To compare the cardiovascular safety of degludec and insulin glargine U100 in high-risk T2D patients.
- To evaluate major adverse cardiovascular events (MACE) as a primary outcome.
- To assess rates of severe hypoglycemia associated with each insulin type.
Main Methods:
- Phase 3b, multicenter, international, double-blind, event-driven trial.
- Involved T2D patients aged >50 with prior CVD or >60 with CVD risk factors.
- Randomized 7637 patients to degludec or insulin glargine U100, followed until 633 MACE occurred.
Main Results:
- Degludec was non-inferior to insulin glargine U100 for the primary MACE outcome (HR 0.91; 95% CI 0.78-1.06).
- Significantly lower rates of severe hypoglycemia (RR 0.60) and nocturnal severe hypoglycemia (RR 0.47) with degludec.
- Mean HbA1c reduced from 8.4% to 7.5% in both groups after a median 2-year follow-up.
Conclusions:
- Cardiovascular safety of degludec is comparable to insulin glargine U100 in high-risk T2D patients.
- Degludec demonstrates superiority in reducing severe hypoglycemia risk.
- Degludec may be preferred for patients at risk of severe hypoglycemia, including elderly, those with CVD, or chronic kidney disease.
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