Cardiovascular Safety and Hypoglycemia Risk: Comparing Degludec and Glargine in High-Risk Algerian Patients with Type 2 Diabetes (DEVOTE Study, Sub-population Analysis)

Author(s)

ABSTRACT WITHDRAWN

OBJECTIVES: Diabetes is a pressing worldwide public-health problem with many challenges including the growing prevalence, micro-and macrovascular complications, late diagnosis and poor awareness. In this work we analyzed the sub-population of patients included in Algeria from the international multicenter DEVOTE trial.

METHODS: DEVOTE trial was a randomized double-blind trial. Patients were randomly assigned to receive once-daily insulin Degludec or insulin Glargine.

The primary outcome was the first occurrence of an adjudicated major adverse cardiovascular event (MACE) and secondary outcome was the occurrence of an adjudicated severe hypoglycemia.

RESULTS: A total of 7 637 patients diagnosed with type 2 diabetes (T2D) and high cardiovascular risk were included with follow-up of two years. Out of 63 patients were included in Algeria, male in majority (57.1%), with an average age of 63.8 years and mean T2D duration of 15.2 years.

They were 26 assigned in the Degludec group and 37 in the Glargine group. At month 24, HbA1c levels decreased from 8.08 ± 1.51% (mean) to 7.00 ± 0.82%. Lower levels of fasting plasma glucose (FPG) decreased from 9.19 ± 3.00 mmol/L (mean) to 6.71±2.15 mmol/L.

MACE was experienced in 3 patients (8.1%) in the Glargine group while no events were observed in the Degludec group. Within the Glargine group, 15 severe hypoglycemia episodes, including 7 nocturnal episodes, were reported in 3 patients (8.1%). In contrast, no severe diurnal or nocturnal hypoglycemia episodes were reported with Degludec.

CONCLUSIONS: Degludec demonstrates favorable outcomes in high cardiovascular risk patients with T2D, suggesting a substantial benefit on cardiovascular events and the severity of diurnal and nocturnal hypoglycemia. These findings highlight the importance of considering specific clinical perspectives when assessing treatment options for T2D in Algeria.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Code

CO31

Topic

Clinical Outcomes, Study Approaches

Topic Subcategory

Clinical Trials, Comparative Effectiveness or Efficacy

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity)

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