medwireNews: Insulin-naïve people with type 2 diabetes initiating the second-generation basal insulins glargine 300 or degludec 100 experience similar improvements in glycated hemoglobin (HbA1c) levels, show data from the real-world RESTORE-2 study.
Speaking at the virtual 57th EASD Annual Meeting, Gian Paolo Fadini (University of Padova, Italy) told delegates that during 6 months of treatment average HbA1c levels fell from a baseline of 9.25% (77 mmol/mol) to 7.55% (59 mmol/mol), a 1.70% improvement, in 357 people who began treatment with insulin glargine 300 U/mL between 2017 and 2020.
This was not significantly different from the 1.69% improvement, from a baseline of 9.18%, observed among the 357 propensity-matched individuals who initiated insulin degludec 100 U/mL during the same period, with the between-group mean difference of 0.01% falling within the 0.30% margin for noninferiority.
Mean fasting blood glucose levels fell by a significant 63 mg/dL (3.49 mmol/L) from baseline to 6 months in the glargine group and by a significant 61 mg/dL (3.38 mmol/L) in the degludec group.
In both groups, the mean insulin dose was initially 0.15 U/kg (approximately 12 units/day) increasing to 0.20 U/kg (approximately 16 units/day) at 6 months, and Fadini noted that bodyweight changes were minor with each of the treatments.
He also pointed out that there was no difference in hypoglycemia rates between the two insulins.
Specifically, hypoglycemia incidence was 0.13 and 0.14 episodes per patient–month in the first 6 months in the glargine and degludec groups, respectively, when considering a blood glucose level below 70 mg/dL (3.9 mmol/L). When the hypoglycemia cutoff was reduced to 54 mg/dL (3.0 mmol/L), the incidence rate was 0.02 episodes per patient–month in both groups. There were no severe hypoglycemic episodes in either group.
Post-hoc analysis showed that the benefits of insulin use were sustained at 12 months. At this timepoint, the mean reduction in HbA1c from baseline was numerically, but not significantly, greater with glargine than with degludec, at 1.71% versus 1.44%, resulting in mean HbA1c levels of 7.55% (59 mmol/mol) and 7.74%, (61 mmol/mol), respectively.
Fadini concluded: “In this Italian retrospective real-world study conducted in patients with type 2 diabetes through electronic medical records, we demonstrated non-inferiority of glargine 300 versus degludec 100.”
He added that the results are consistent with those of the randomized, controlled BRIGHT trial and the real-world DELIVER Naïve D study and may “contribute to overcoming clinical inertia in initiation of basal insulin and dose titration in insulin naïve people with type 2 diabetes.”
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