Cardiovascular Safety and Hypoglycemia Risk: Comparing Degludec and Glargine in High-Risk Algerian Patients With Type 2 Diabetes (DEVOTE Study, Subpopulation Analysis)
Author(s)
Nassim NOURI, MD, Prof.1, Mohamed ARRAR, MD, Prof.2, Fatima BENOUN, MD.3, Samia BOUREZANE, MD.4, Al Kassem LEZZAR, MD, Prof.1, Kheira TALHA, MD, Prof.5, Assia ZEDDOUR MOHAMED BRAHIM, MD.6, Daoud ROULA, MD, Prof.7.
1Endocrino-Diabetology Department, CHU Ibn Badis, Constantine, Algeria, 2Internal Medicine Department, CHU Oran, Oran, Algeria, 3Diabetic House Gambetta, Sidi Bel Abbes, Algeria, 4Diabetic House Bouzareah, Algiers, Algeria, 5Endocrino-Diabetology Department, CHU AEK HASSANI, Sidi Bel Abbes, Algeria, 6Novo Nordisk Algeria, Algiers, Algeria, 7Internal Medicine Department, CHU Ibn Badis, Constantine, Algeria.
1Endocrino-Diabetology Department, CHU Ibn Badis, Constantine, Algeria, 2Internal Medicine Department, CHU Oran, Oran, Algeria, 3Diabetic House Gambetta, Sidi Bel Abbes, Algeria, 4Diabetic House Bouzareah, Algiers, Algeria, 5Endocrino-Diabetology Department, CHU AEK HASSANI, Sidi Bel Abbes, Algeria, 6Novo Nordisk Algeria, Algiers, Algeria, 7Internal Medicine Department, CHU Ibn Badis, Constantine, Algeria.
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 the 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. Of these, 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. There 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 regarding 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.
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 the 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. Of these, 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. There 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 regarding 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
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO38
Topic
Clinical Outcomes, Epidemiology & Public Health, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity)