Efficacy and safety of basal insulin degludec 100 IU/mL versus glargine 300 IU/mL for type 1 diabetes: The single-center INEOX randomized controlled trial

Aims: To compare efficacy and safety of degludec 100 IU/mL (Deg-100) and glargine 300 IU/mL (Gla-300) in adults with type 1 diabetes. Methods: Open-label, single-center, randomized, parallel-group, 24-week trial in adults with type 1 diabetes, on basal-bolus insulin therapy, HbA1c <= 10%, using self-monitoring blood glucose. Participants were randomized 1:1 to a basal-bolus insulin regimen with Deg-100 (N = 129) or Gla-300 (N = 131). Primary efficacy endpoint: mean change in HbA1c from baseline to week-24. Main safety outcome: incidence rate of hypoglycemia during the study. Quality of life (DQOL) and satisfaction with diabetes treatment (DTSQ) were assessed. Results: At week 24, after adjusting for baseline HbA1c, the decrease in HbA1c did not differ between groups: Deg-100 (-0.07 +/- 0.7%) and Gla-300 (-0.16 +/- 0.77%) (P = 0.320). There were no significant differences between groups in HbA1c, nocturnal hypoglycemia, severe hypoglycemia, DQOL, or DTSQ scores. The incidence rates of hypoglycemia < 3.9 mmol/L (Deg-100: 115.24 events/person-year vs Gla-300: 99.01 events/person-year, p < 0.001); and < 3.0 mmol/L (Deg-100: 41.17 events/person-year vs Gla-300: 34.29 events/person-year, p < 0.001) were different between groups. Conclusions: Deg-100 and Gla-300 have similar metabolic efficacy, incidence ratio of nocturnal and severe hy-poglycemia, DQOL and DTSQ scores. Differences in the incidence rate of hypoglycemia < 3.9 mmol/L and < 3.0 mmol/L should be confirmed.

Automated summary

This study aimed to compare the efficacy and safety of Deg-100 and Gla-300 in adults with type 1 diabetes. The results showed no significant difference in reducing HbA1c between Deg-100 and Gla-300 after 24 weeks. There were no significant differences in HbA1c, nocturnal hypoglycemia, severe hypoglycemia, DQOL, or DTSQ scores between the two groups. However, the incidence rates of hypoglycemia below 3.9mmol/L and 3.0mmol/L were different between the groups and require further confirmation.